S4335-Awm
by Samsung Electronics Co., Ltd.
S4335-Awm is an indirect flat panel x-ray detector (FDA Class II; FDA product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager)) made by Samsung Electronics Co., Ltd., cleared under FDA 510(k) K220175 on 21 Apr 2022 and listed in FDA GUDID since 4 May 2022 (UDI-DI 08806094458213), active as of 23 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 | Number08806094458213 | Date4 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220175 | Date21 Apr 2022 | StatusActive |
Official records
- AccessGUDID record 08806094458213
- FDA 510(k) database K220175
Across registries
- FDA 510(k) K220175 decided 21 Apr 2022 Active
- FDA GUDID UDI-DI 08806094458213 listed 4 May 2022 Listed
Timeline
- Cleared FDA 510(k) K220175
- Listed FDA GUDID 08806094458213
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Indirect flat panel x-ray detector
- Model / reference
- S4335-AWM
- Primary DI / UDI-DI
- 08806094458213
- 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.