A1417MCW
A1417MCW is a Class II device made by H&abyz Co., Ltd., cleared under FDA 510(k) K223930 on 6 Mar 2023 and listed in FDA GUDID since 7 Apr 2023 (UDI-DI 08800070400036), active as of 21 Oct 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 | Number08800070400036 | Date7 Apr 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223930 | Date6 Mar 2023 | StatusActive |
Official records
- AccessGUDID record 08800070400036
- FDA 510(k) database K223930
Across registries
- FDA 510(k) K223930 decided 6 Mar 2023 Active
- FDA GUDID UDI-DI 08800070400036 listed 7 Apr 2023 Listed
Timeline
- Cleared FDA 510(k) K223930
- Listed FDA GUDID 08800070400036
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Indirect flat panel x-ray detector
- Model / reference
- A1417MCW
- Primary DI / UDI-DI
- 08800070400036
- 510(k) Number
- FDA product code
- MQB
- GMDN term
- Indirect flat panel x-ray detector
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Indirect flat panel x-ray detector.