Nuclear Max
FDA 510(k) K900773 · Scientific Imaging, Inc.
510(k) numberK900773
Submission
- Device name
- Nuclear Max
- Applicant
- Scientific Imaging, Inc.
Littleton, CO, US - Received
- February 16, 1990
- Decision date
- May 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Nuclear Max cleared by the FDA?
Nuclear Max (K900773) received a 510(k) decision of Substantially Equivalent on May 23, 1990, 96 days after the submission was received.
What is the product code of K900773?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.