Carestream Health, Inc.
FDA 510(k) & PMA Approved Devices — 23 products
Total Devices23
Categories5
Latest Approval2025-09-04
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K251168 | Image Suite | LLZ | 2025-09-04 | View |
| 510(k) | K241505 | DRX-Revolution Mobile X-ray System | IZL | 2024-12-10 | View |
| 510(k) | K233381 | DRX-Evolution Plus System | KPR | 2024-03-12 | View |
| 510(k) | K223842 | DRX - Compass | KPR | 2023-01-20 | View |
| 510(k) | K213307 | Eclipse II with Smart Noise Cancellation | MQB | 2022-01-14 | View |
| 510(k) | K202441 | Eclipse II with Smart Noise Cancellation | MQB | 2021-04-02 | View |
| 510(k) | K201373 | DRX-Compass | KPR | 2020-06-26 | View |
| 510(k) | K192894 | Vita Flex CR System with LLI | MQB | 2020-02-18 | View |
| 510(k) | K193574 | Q-Rad System | KPR | 2020-01-22 | View |
| 510(k) | K191879 | DRX-Evolution with Carestream Digital Tomosynthesis | KPR | 2019-12-20 | View |
| 510(k) | K190330 | DRX-Evolution/Plus with Dual Energy | KPR | 2019-11-04 | View |
| 510(k) | K191025 | DRX-Revolution Mobile X-ray System | IZL | 2019-05-17 | View |
| 510(k) | K183245 | Carestream DRX-1 System with DRX Plus 2530 Detectors | MQB | 2019-02-08 | View |
| 510(k) | K183474 | Carestream DRX-1 System with DRX Core Detectors | MQB | 2019-01-16 | View |
| 510(k) | K180809 | Eclipse II | MQB | 2018-06-21 | View |
| 510(k) | K180667 | SmartGrid | MQB | 2018-04-13 | View |
| 510(k) | K173924 | DRX-Revolution Nano Mobile X-ray System | IZL | 2018-02-05 | View |
| 510(k) | K173478 | OnSight 3D Extremity System | JAK | 2018-01-19 | View |
| 510(k) | K170755 | DRX-Revolution Nano Mobile X-ray System | IZL | 2017-06-21 | View |
| 510(k) | K170580 | Carestream Vue PACS | LLZ | 2017-04-11 | View |
| 510(k) | K163203 | Carestream DRX-Evolution | KPR | 2016-12-13 | View |
| 510(k) | K160723 | OnSight 3D Extremity System | JAK | 2016-08-30 | View |
| 510(k) | K153103 | CARESTREAM Vue PACS | LLZ | 2016-02-12 | View |
No matching devices.