The following data is part of a premarket notification filed by Machlett Laboratories, Inc. with the FDA for Gamma Camera.
| Device ID | K780969 |
| 510k Number | K780969 |
| Device Name: | GAMMA CAMERA |
| Classification | Camera, Scintillation (gamma) |
| Applicant | MACHLETT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-12 |
| Decision Date | 1978-06-27 |