The following data is part of a premarket notification filed by Digisonics, Inc. with the FDA for Doctors Review System.
| Device ID | K970402 |
| 510k Number | K970402 |
| Device Name: | DOCTORS REVIEW SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | DIGISONICS, INC. 3701 KIRBY DR., SUITE 930 Houston, TX 77098 |
| Contact | Diana Mc Sherry, Ph.d |
| Correspondent | Diana Mc Sherry, Ph.d DIGISONICS, INC. 3701 KIRBY DR., SUITE 930 Houston, TX 77098 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857050006014 | K970402 | 000 |
| 00857050006007 | K970402 | 000 |
| 00857050006021 | K970402 | 000 |
| 00857050006038 | K970402 | 000 |