Sedecal
The SEDECAL X PLUS (LP) PLUS Radiographic Systems with (or without) Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects…
The SEDECAL X PLUS (LP) PLUS Radiographic Systems with (or without) Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
13manufacturers in China registered for this device type
70catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (4), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| iRay Group | Shanghai | Shanghai | Specification developer | 4 |
| Fujifilm Imaging System (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Showing 12 of 13. All 13 manufacturers in China registered for Solid State X-Ray Imager (Flat Panel/Digital Imager)
Record
| Listed by | Sedecal., Sa., Spain |
|---|---|
| FDA product code | MQB |
| Device type | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| 510(k) | K192011 |
| Record published | 2025-03-21 |
| Record revised | 2022-09-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 40 °C; Storage environment humidity 20 to 85 % RH; Storage environment atmospheric pressure 700 to 1060 millibar; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 700 to 1060 millibar |
| Distribution end date | 2025-01-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ODYSSEY+ | In distribution | |
| Soltus 500 | In distribution | |
| PhoeniX | In distribution | |
| RAD SYSTEM NOVA FA | In distribution | |
| SPSLW8 | In distribution | |
| MILLENNIUM (Proteus XR/i) | In distribution | |
| PhoeniX | In distribution | |
| ODYSSEY | In distribution | |
| Proteus XR/f ST | In distribution | |
| PhoeniX | In distribution | |
| ODYSSEY+ | In distribution | |
| SEDECAL X PLUS LP | In distribution | |
| AeroDR TX m01 | In distribution | |
| SM-40HF-Batt | In distribution | |
| MULTIRAD (PROTEUS XR/e) | In distribution | |
| AeroDR TX m01 | In distribution | |
| SPSL8HC | In distribution | |
| ODYSSEY+ | In distribution | |
| Soltus 450 | In distribution | |
| SM-20HF-B-D-C | In distribution | |
| PhoeniX | In distribution | |
| SEDECAL X PLUS (LP) PLUS | In distribution | |
| SM-32HF-Batt | In distribution | |
| AeroDR TX m01 | In distribution | |
| MILLENNIUM | In distribution | |
| Soltus 450 | In distribution | |
| MULTIRAD | In distribution | |
| Soltus 500 | In distribution | |
| PhoeniX | In distribution | |
| ODYSSEY+ | In distribution | |
| SPSLW4 | In distribution | |
| SM-20HF-Batt | In distribution | |
| PhoeniX | In distribution | |
| SM-40HF-B-D-C | In distribution | |
| SM-50HF-B-D-C | In distribution | |
| ODYSSEY | In distribution | |
| RAD SYSTEM NOVA ST | In distribution | |
| SM-50HF-Batt | In distribution | |
| ODYSSEY | In distribution | |
| MILLENIUM PLUS TPC | In distribution | |
| PhoeniX | In distribution | |
| PhoeniX | In distribution | |
| RAD SYSTEM NOVA AT | In distribution | |
| Soltus 450 | In distribution | |
| PhoeniX | In distribution | |
| PhoeniX | In distribution | |
| PhoeniX | In distribution | |
| PhoeniX | In distribution | |
| ODYSSEY | In distribution | |
| Soltus 450 | In distribution | |
| MILLENNIUM PLUS AT | In distribution | |
| SPSL4HC | In distribution | |
| PhoeniX | In distribution | |
| SM-32HF-B-D-C | In distribution | |
| Proteus XR/f ET | In distribution | |
| Soltus 500 | In distribution | |
| PhoeniX | In distribution | |
| AeroDR TX m01 | In distribution | |
| SM-20HF-B-D-KM (AeroDR X30) | Withdrawn | |
| SM-50HF-B-D-KM (AeroDR X30) | Withdrawn | |
| SM-20HF-B-D-T | Withdrawn | |
| SM-40HF-B-D-KM (AeroDR X30) | Withdrawn | |
| SM-40HF-B-D-T | Withdrawn | |
| SM-50HF-B-D-T | Withdrawn | |
| SM-32HF-B-D-T | Withdrawn | |
| SM-32HF-B-D-KM (AeroDR X30) | Withdrawn | |
| Proteus XR/f ST | Withdrawn | |
| SM-40HF-B-D-VIR | Withdrawn | |
| MobileDiagnost wDR | Withdrawn | |
| Proteus XR/f ET | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Schick33 | Sirona Dental, Inc. | 44 |
| Drgem | Drgem Corporation | 41 |
| Schick | Dentsply LLC | 35 |
| Wireless Digital Flat Panel Detector | iRay Group | 27 |
| Fuji IP Cassette CC | Fujifilm Corporation | 20 |
| Canon Inc. | Canon Inc. | 20 |
| Fona Stellaris | Sirona Dental, Inc. | 20 |
| Exprimer | Drtech Corporation | 18 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Samsung Electronics Co., Ltd. | 17 |
| X-ray Flat Panel Detector | Careray Digital Medical Technology Co., Ltd. | 16 |
| Regius Cassette | Konica Minolta, Inc. | 16 |
| Aadco | Aadco Medical, Inc. | 15 |
Showing 12 of 509. All products under Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133782 | 2014-03-21 |
| K130883 | 2013-04-18 |
| K063283 | 2006-11-17 |
Recalls Naming This Product
49 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 56 units |
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 55 units |
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 1 unit |
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 268 units |
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 8 units |
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 12 units |
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 1 unit |
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 12 units |
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 7 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 1 unit |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 1 unit |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 8 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 22 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 6 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 39 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 1 unit |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 14 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 9 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 8 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 4 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 27 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 5 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 1 unit |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 5 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 2 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 1 unit |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 4 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 181 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 1 unit |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 10 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 6 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 1 unit |
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 1 unit |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 142 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 6 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 6 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 6 units |
| Sedecal S.A. | UDI-DI | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | 24 units |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning | |
| Sedecal S.A. | 510(k) number | 2025-06-10 | Class II | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning |
Showing 40 of 49.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.