PicomEnterprise 3.x
PicomEnterprise 3.x is a radiological PACS-dedicated management software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Scimage, Inc., cleared under FDA 510(k) K073169 on 9 Jan 2008 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00861917000305), 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 | Number00861917000305 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK073169 | Date9 Jan 2008 | StatusActive |
Official records
- AccessGUDID record 00861917000305
- FDA 510(k) database K073169
Across registries
- FDA 510(k) K073169 decided 9 Jan 2008 Active
- FDA GUDID UDI-DI 00861917000305 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K073169
- Listed FDA GUDID 00861917000305
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PicomEnterprise
- Generic name
- Radiological PACS-dedicated management software
- Model / reference
- 3.x
- Primary DI / UDI-DI
- 00861917000305
- 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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