Medws 5.4
by Med.e.com
Medws 5.4 is a Class II device made by Med.e.com, cleared under FDA 510(k) K132684 on 23 May 2014 and listed in FDA GUDID since 2 Aug 2021 (UDI-DI 03665587000071), active as of 12 Nov 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 | Number03665587000071 | Date2 Aug 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132684 | Date23 May 2014 | StatusActive |
Official records
- AccessGUDID record 03665587000071
- FDA 510(k) database K132684
Across registries
- FDA 510(k) K132684 decided 23 May 2014 Active
- FDA GUDID UDI-DI 03665587000071 listed 2 Aug 2021 Listed
Timeline
- Cleared FDA 510(k) K132684
- Listed FDA GUDID 03665587000071
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medws
- Generic name
- Diagnostic x-ray digital imaging system workstation application software
- Model / reference
- 5.4
- Primary DI / UDI-DI
- 03665587000071
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Diagnostic x-ray digital imaging system workstation application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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