Carestream DRX-1 System
by Carestream Health, Inc. 2 variants
510(k) K150766
Carestream DRX-1 System is a Class II device made by Carestream Health, Inc., cleared under FDA 510(k) K150766 on 24 Jun 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150766 | Date24 Jun 2015 | StatusActive |
Official records
- FDA 510(k) database K150766
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K150766
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 4343R Digital Image Receptor | 8607582 / 4343R Digital Image Receptor | 60889978607587 | — | On the market |
| DRX Core 3543 Detector | AD8200 / DRX Core 3543 Detector | 60889974008463 | — | On the market |
| DRX Core 3543C Detector | AD8201 / DRX Core 3543C Detector | 60889974008470 | — | On the market |
| DRX Plus 3543 Detector | AC2600 / DRX Plus 3543 Detector | 60889974000221 | — | On the market |
| DRX Plus 3543 Detector | AL6750 / DRX Plus 3543 Detector | 60889975950532 | — | On the market |
| DRX Plus 3543C Detector | AC2603 / DRX Plus 3543C Detector | 60889974000238 | — | On the market |
| DRX Plus 3543C Detector | AL6755 / DRX Plus 3543C Detector | 60889975950549 | — | On the market |
| TRIMAX 3543 Detector DETECTOR, PACKED, TRIMAX, 3543 | AE4200 / DETECTOR,PACKED,TRIMAX,3543 | 60889974160185 | — | On the market |
| TRIMAX 3543C Detector DETECTOR, PACKED, TRIMAX, 3543C | AE4201 / DETECTOR,PACKED,TRIMAX,3543C | 60889974160192 | — | On the market |
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Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).
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