The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Deltascan 2060 Ct Scanner.
| Device ID | K812410 |
| 510k Number | K812410 |
| Device Name: | DELTASCAN 2060 CT SCANNER |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TECHNICARE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-21 |
| Decision Date | 1981-10-02 |