The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Aquariusaps Server.
| Device ID | K061214 |
| 510k Number | K061214 |
| Device Name: | AQUARIUSAPS SERVER |
| Classification | System, Image Processing, Radiological |
| Applicant | TERARECON, INC. 2955 CAMPUS DR., SUITE 325 San Mateo, CA 94403 |
| Contact | Emilly Tojima |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-02 |
| Decision Date | 2006-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| AQAPS1 | K061214 | 000 |
| AQAPS04 | K061214 | 000 |