The following data is part of a premarket notification filed by Radiological Specialists, Inc. with the FDA for Topacs.
| Device ID | K063294 |
| 510k Number | K063294 |
| Device Name: | TOPACS |
| Classification | System, Image Processing, Radiological |
| Applicant | RADIOLOGICAL SPECIALISTS, INC. 5920 NOBLE AVE. Van Nuys, CA 91411 |
| Contact | Frank Mcmurray |
| Correspondent | Frank Mcmurray RADIOLOGICAL SPECIALISTS, INC. 5920 NOBLE AVE. Van Nuys, CA 91411 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2007-01-24 |
| Summary: | summary |