The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Gold(au 195) Gamma Camera Check(flood).
| Device ID | K812236 |
| 510k Number | K812236 |
| Device Name: | GOLD(AU 195) GAMMA CAMERA CHECK(FLOOD) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-11 |
| Decision Date | 1981-09-09 |