DRX - Ascend System
by Carestream Health, Inc. 123 variants
DRX - Ascend System (1023167) is a Class II device made by Carestream Health, Inc., cleared under FDA 510(k) K011486 on 20 Jun 2001 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 60889971023162), active as of 8 Jun 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number60889971023162 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011486 | Date20 Jun 2001 | StatusActive |
Official records
- AccessGUDID record 60889971023162
- FDA 510(k) database K011486
Across registries
- FDA 510(k) K011486 decided 20 Jun 2001 Active
- FDA GUDID UDI-DI 60889971023162 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K011486
- Listed FDA GUDID 60889971023162
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Stationary basic diagnostic x-ray system, analogue
- Model / Ref / Catalog
- DRX - Ascend System, 1023167
- Primary DI / UDI-DI
- 60889971023162
- 510(k) Number
- FDA product code
- KPR
- GMDN term
- Stationary basic diagnostic x-ray system, analogue
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Stationary basic diagnostic x-ray system, analogue.