CAT-250B
FDA 510(k) K915413 · Toshiba America Medical Systems, In.C
510(k) numberK915413
Submission
- Device name
- CAT-250B
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- December 4, 1991
- Decision date
- December 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was CAT-250B cleared by the FDA?
CAT-250B (K915413) received a 510(k) decision of Substantially Equivalent on December 19, 1991, 15 days after the submission was received.
What is the product code of K915413?
The FDA product code is IZZ – Table, Radiographic, Non-Tilting, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.1980.