Solid State X-Ray Imager (Flat Panel/Digital Imager)
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or…
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
13manufacturers in China registered for this device type
17catalogue numbers in this listing
4510(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 | Samsung Electronics Co., Ltd., South Korea |
|---|---|
| FDA product code | MQB |
| Device type | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K222353 |
| Record published | 2022-10-20 |
| Record revised | 2021-10-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F4335-AW | In distribution | |
| GR40CWC | In distribution | |
| S4343-AW | In distribution | |
| GC80 | In distribution | |
| S4343-W | In distribution | |
| GR40CW | In distribution | |
| S4335-WV | In distribution | |
| F4343-AW | In distribution | |
| GM85 | In distribution | |
| S4335-W | In distribution | |
| GR40CW | In distribution | |
| GR40CWD | In distribution | |
| S3025-W | In distribution | |
| S4343-AWM | In distribution | |
| S4335-AWM | In distribution | |
| GM60A-32S | In distribution | |
| S4335-AW | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sedecal | Sedecal., Sa. | 70 |
| 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 |
| 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 |
|---|---|
| K181631 | 2018-07-20 |
| K153401 | 2015-12-21 |
| K152094 | 2015-10-16 |
| K140235 | 2014-05-15 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Samsung HME America, Inc. | 510(k) number | 2025-10-07 | Class II | Device Design | The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue. | 236 units | |
| Samsung HME America, Inc. | 510(k) number | 2024-07-08 | Class II | Device Design | Potential for the anti-fall system of the device arm to fail. | 31 units | |
| Samsung HME America, Inc. | 510(k) number | 2023-12-28 | Class II | Process design | Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm. | 261 devices | |
| Samsung HME America, Inc. | 510(k) number | 2023-03-08 | Class II | Device Design | Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm | 935 units | |
| Samsung HME America, Inc. | 510(k) number | 2019-05-06 | Class II | Process control | Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks. | 288 systems | 2020-06-10 |
| Samsung HME America, Inc. | 510(k) number | 2017-06-22 | Class II | Other | An image was obtained with over exposure during a Thorax examination using the AEC function. | 45 units | 2018-10-05 |
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.