The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Omega 500 Rectangular Field Camera W/sc.
| Device ID | K813073 |
| 510k Number | K813073 |
| Device Name: | OMEGA 500 RECTANGULAR FIELD CAMERA W/SC |
| Classification | Camera, Scintillation (gamma) |
| Applicant | TECHNICARE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-02 |
| Decision Date | 1981-12-08 |