Gold(Au 195) Gamma Camera Check(Flood)
FDA 510(k) K812236 · Amersham Corp.
510(k) numberK812236
Submission
- Device name
- Gold(Au 195) Gamma Camera Check(Flood)
- Applicant
- Amersham Corp.
Mchenry, IL, US - Received
- August 11, 1981
- Decision date
- September 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Gold(Au 195) Gamma Camera Check(Flood) cleared by the FDA?
Gold(Au 195) Gamma Camera Check(Flood) (K812236) received a 510(k) decision of Substantially Equivalent on September 9, 1981, 29 days after the submission was received.
What is the product code of K812236?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.