The following data is part of a premarket notification filed by Scientific Imaging, Inc. with the FDA for Nuclear Max.
| Device ID | K900773 |
| 510k Number | K900773 |
| Device Name: | NUCLEAR MAX |
| Classification | Camera, Scintillation (gamma) |
| Applicant | SCIENTIFIC IMAGING, INC. 6032 S.BROOK VALLEY WAY Littleton, CO 80121 |
| Contact | Lear, M.d. |
| Correspondent | Lear, M.d. SCIENTIFIC IMAGING, INC. 6032 S.BROOK VALLEY WAY Littleton, CO 80121 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-05-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NUCLEAR MAX 74181825 1742200 Dead/Cancelled |
MEDX, INCORPORATED 1991-07-02 |