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 |