The following data is part of a premarket notification filed by Teknomed, Inc. with the FDA for Tecnotomo.
| Device ID | K790132 |
| 510k Number | K790132 |
| Device Name: | TECNOTOMO |
| Classification | System, X-ray, Tomographic |
| Applicant | TEKNOMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-23 |
| Decision Date | 1979-02-21 |