GCA-9300 Nuclear Tomography System
FDA 510(k) K901545 · Toshiba America Medical Systems, In.C
510(k) numberK901545
Submission
- Device name
- GCA-9300 Nuclear Tomography System
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- April 3, 1990
- Decision date
- June 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was GCA-9300 Nuclear Tomography System cleared by the FDA?
GCA-9300 Nuclear Tomography System (K901545) received a 510(k) decision of Substantially Equivalent on June 26, 1990, 84 days after the submission was received.
What is the product code of K901545?
The FDA product code is JWM – System, Tomographic, Nuclear, a Class II (moderate risk) device regulated under 21 CFR 892.1310.