The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Aquariusnet Server.
| Device ID | K012086 |
| 510k Number | K012086 |
| Device Name: | AQUARIUSNET SERVER |
| Classification | System, Image Processing, Radiological |
| Applicant | TERARECON, INC. 200 GREGORY LN. SUITE C-100 Pleasent Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf TERARECON, INC. 200 GREGORY LN. SUITE C-100 Pleasent Hill, CA 94523 -3389 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-03 |
| Decision Date | 2001-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| INTUITION7 | K012086 | 000 |
| INTUITION3 | K012086 | 000 |
| INTUITION2 | K012086 | 000 |
| INTUITION9 | K012086 | 000 |
| INTUITION12 | K012086 | 000 |