AquariusAPS
AquariusAPS is a Class II device made by Terarecon Inc., cleared under FDA 510(k) K061214 on 15 May 2006 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI AQAPS1), 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 | NumberAQAPS1 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061214 | Date15 May 2006 | StatusActive |
Official records
- FDA 510(k) database K061214
Across registries
- FDA 510(k) K061214 decided 15 May 2006 Active
- FDA GUDID UDI-DI AQAPS1 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K061214
- Listed FDA GUDID AQAPS1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radiological PACS-dedicated management software
- Model / reference
- AquariusAPS
- Primary DI / UDI-DI
- AQAPS1
- 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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