The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Saturn Nuclear Medicine Computer System.
| Device ID | K852089 |
| 510k Number | K852089 |
| Device Name: | SATURN NUCLEAR MEDICINE COMPUTER SYSTEM |
| Classification | Camera, Scintillation (gamma) |
| Applicant | TECHNICARE CORP. P.O. BOX 5130 Cleveland, OH 44101 |
| Contact | Raymond E Ursick |
| Correspondent | Raymond E Ursick TECHNICARE CORP. P.O. BOX 5130 Cleveland, OH 44101 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-13 |
| Decision Date | 1985-07-18 |