The following data is part of a premarket notification filed by Strichman Medical Equipment, Inc. with the FDA for Gamma 600 Nuclear Medicine Computer.
| Device ID | K903469 |
| 510k Number | K903469 |
| Device Name: | GAMMA 600 NUCLEAR MEDICINE COMPUTER |
| Classification | Camera, Scintillation (gamma) |
| Applicant | STRICHMAN MEDICAL EQUIPMENT, INC. 93 WEST TECH CENTER Medfield, MA 02052 |
| Contact | Mark Doherty |
| Correspondent | Mark Doherty STRICHMAN MEDICAL EQUIPMENT, INC. 93 WEST TECH CENTER Medfield, MA 02052 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-01 |
| Decision Date | 1991-02-04 |