Aquariusaps Server
510(k) K061214
Aquariusaps Server is a Class II device made by Terarecon Inc., cleared under FDA 510(k) K061214 on 15 May 2006, 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 | FDA 510(k)SESE | NumberK061214 | Date15 May 2006 | StatusActive |
Official records
- FDA 510(k) database K061214
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Terarecon,Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K061214
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| AQAPS AQAPS04 | AQAPS / AQAPS04 | AQAPS04 | On the market | |
| AquariusAPS | AquariusAPS | AQAPS1 | On the market |
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