TF-63SA
FDA 510(k) K904044 · Toshiba America Medical Systems, In.C
510(k) numberK904044
Submission
- Device name
- TF-63SA
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- September 4, 1990
- Decision date
- November 29, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was TF-63SA cleared by the FDA?
TF-63SA (K904044) received a 510(k) decision of Substantially Equivalent on November 29, 1990, 86 days after the submission was received.
What is the product code of K904044?
The FDA product code is KPW – Device, Beam Limiting, X-Ray, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1610.