The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Iivs Integrated Image Viewing Station.
| Device ID | K994329 |
| 510k Number | K994329 |
| Device Name: | IIVS INTEGRATED IMAGE VIEWING STATION |
| Classification | System, Digital Image Communications, 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 | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-22 |
| Decision Date | 2000-05-26 |
| Summary: | summary |