The following data is part of a premarket notification filed by Medasys, Inc. with the FDA for Digital Nuclear Imaging System.
| Device ID | K875198 |
| 510k Number | K875198 |
| Device Name: | DIGITAL NUCLEAR IMAGING SYSTEM |
| Classification | Camera, Scintillation (gamma) |
| Applicant | MEDASYS, INC. 4651 PLATT RD. Ann Arbor, MI 48108 |
| Contact | Ffred Matzinger |
| Correspondent | Ffred Matzinger MEDASYS, INC. 4651 PLATT RD. Ann Arbor, MI 48108 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-17 |
| Decision Date | 1988-07-01 |