Radmedix AccuVue+ 5
Radmedix AccuVue+ 5 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Radmedix, LLC, cleared under FDA 510(k) K201058 on 6 May 2020 and listed in FDA GUDID since 9 Jun 2020 (UDI-DI 00810035220379), 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 | GUDID listing | Number00810035220379 | Date9 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201058 | Date6 May 2020 | StatusActive |
Official records
- AccessGUDID record 00810035220379
- FDA 510(k) database K201058
Across registries
- FDA 510(k) K201058 decided 6 May 2020 Active
- FDA GUDID UDI-DI 00810035220379 listed 9 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K201058
- Listed FDA GUDID 00810035220379
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Radmedix AccuVue+
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 5
- Primary DI / UDI-DI
- 00810035220379
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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