The following data is part of a premarket notification filed by Tomtec Imaging Systems, Inc. with the FDA for Tomtecp90.
| Device ID | K950279 |
| 510k Number | K950279 |
| Device Name: | TOMTECP90 |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | TOMTEC IMAGING SYSTEMS, INC. 4775 WALNUT ST. SUITE C Boulder, CO 80301 |
| Contact | Lisa Cassidy |
| Correspondent | Lisa Cassidy TOMTEC IMAGING SYSTEMS, INC. 4775 WALNUT ST. SUITE C Boulder, CO 80301 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-24 |
| Decision Date | 1995-09-15 |