Joints 5.28
Joints 5.28 is a radiological PACS-dedicated management software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Medstrat, Inc., cleared under FDA 510(k) K051745 on 14 Jul 2005 and listed in FDA GUDID since 19 Feb 2022 (UDI-DI 00817886020417), 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 | Number00817886020417 | Date19 Feb 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051745 | Date14 Jul 2005 | StatusActive |
Official records
- AccessGUDID record 00817886020417
- FDA 510(k) database K051745
Across registries
- FDA 510(k) K051745 decided 14 Jul 2005 Active
- FDA GUDID UDI-DI 00817886020417 listed 19 Feb 2022 Listed
Timeline
- Cleared FDA 510(k) K051745
- Listed FDA GUDID 00817886020417
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Joints
- Generic name
- Radiological PACS-dedicated management software
- Model / reference
- 5.28
- Primary DI / UDI-DI
- 00817886020417
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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