Sedecal
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic…
This Portable Diagnostic Radiographic System is 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)
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| Suzhou Powersite Electric Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Sedecal., Sa., Spain |
|---|---|
| FDA product code | IZL |
| Device type | System, X-Ray, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1720 |
| 510(k) | K232185 |
| Record published | 2023-09-19 |
| Record revised | 2018-07-06 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SM-IV | In distribution | |
| SM-V | In distribution | |
| SM-V | In distribution | |
| SM-V | In distribution | |
| SPL-HF-8.0 | In distribution | |
| SM-V | In distribution | |
| PhoeniX | In distribution | |
| PhoeniX | In distribution | |
| SPSL-HF-8.0-APR | In distribution | |
| SM-V | In distribution | |
| SPL-HF-2.0 | In distribution | |
| SM-IV | In distribution | |
| SM-IV | In distribution | |
| SPL-HF-4.0 | In distribution | |
| SM-V | In distribution | |
| SPSL-HF-4.0-APR | In distribution | |
| SM-IV | In distribution | |
| SPSL-HF-8.0 | In distribution | |
| SPSL-HF-4.0 | In distribution | |
| Soltus 500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Siui | Shantou Institute OF Ultrasonic Instruments Co., Ltd. | 27 |
| AcuityPDR | RadmediX, LLC | 24 |
| Drgem | Drgem Corporation | 10 |
| DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 7 |
| MinXray | Minxray, Inc. | 6 |
| System, X-Ray, Mobile | Ecotron Co., Ltd. | 6 |
| MobileDaRt Evolution | Shimadzu Corp. | 5 |
| Nomad MD™ handheld X-ray system | Aribex, Inc. | 5 |
| Portable X-ray Unit | Ajex Meditech., Ltd. | 5 |
| Diagnostic X-ray Unit | Poskom Co., Ltd. | 4 |
| FDR Aqro | Fujifilm Corporation | 4 |
| Optima | GE Medical Systems, L.L.C. | 4 |
Showing 12 of 75. All products under System, X-Ray, Mobile
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232185 | 2023-08-21 |
| K222951 | 2022-11-21 |
| K221803 | 2022-07-18 |
| K212291 | 2021-09-14 |
| K192936 | 2019-11-15 |
| K192011 | 2019-09-25 |
| K191813 | 2019-08-02 |
| K173299 | 2018-01-26 |
| K161345 | 2016-07-06 |
| K141895 | 2014-09-18 |
| K121410 | 2012-08-02 |
| K101517 | 2011-08-05 |
| K111725 | 2011-07-19 |
| K103522 | 2011-01-26 |
| K090322 | 2009-03-17 |
| K043002 | 2004-11-18 |
| K020436 | 2002-02-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Sedecal S.A. | 510(k) number | 2022-08-12 | Class II | Software design | Due to un-commanded movement of mobile x-ray unit. | 155 systems |
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.