The following data is part of a premarket notification filed by Tomogscanner Ok Ltd. with the FDA for Tomogscanner 2.
| Device ID | K781753 |
| 510k Number | K781753 |
| Device Name: | TOMOGSCANNER 2 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | TOMOGSCANNER OK LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-17 |
| Decision Date | 1978-11-03 |