The following data is part of a premarket notification filed by Gamma Medica with the FDA for Lumagem Scintillation Camera.
| Device ID | K993813 |
| 510k Number | K993813 |
| Device Name: | LUMAGEM SCINTILLATION CAMERA |
| Classification | Camera, Scintillation (gamma) |
| Applicant | GAMMA MEDICA 19355 BUSINESS CENTER DR., SUITE 8 Northridge, CA 91324 |
| Contact | Bradley E Patt |
| Correspondent | Bradley E Patt GAMMA MEDICA 19355 BUSINESS CENTER DR., SUITE 8 Northridge, CA 91324 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-10 |
| Decision Date | 2000-01-18 |
| Summary: | summary |