Optima
Designated Medical Device Assembly, Optima XR240amx HD Upgrade
13manufacturers in China registered for this device type
1catalogue number
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 | GE Medical Systems, L.L.C. |
|---|---|
| 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) | K162990 |
| Record published | 2019-07-15 |
| Record revised | 2026-02-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-10-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XR240amx HD Upgrade Gen2 | Withdrawn |
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 |
| 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 |
Showing 12 of 509. All products under Solid State X-Ray Imager (Flat Panel/Digital Imager)
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2026-06-05 | Class II | Process control | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the i | 24 units |
| GE Medical Systems, LLC | 510(k) number | 2024-11-25 | Class II | Component design/selection | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the inte | 120 units |
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.