Angiorex C/N (Angiographic X-Ray System)
FDA 510(k) K897115 · Toshiba America Medical Systems, In.C
510(k) numberK897115
Submission
- Device name
- Angiorex C/N (Angiographic X-Ray System)
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- December 26, 1989
- Decision date
- March 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Angiorex C/N (Angiographic X-Ray System) cleared by the FDA?
Angiorex C/N (Angiographic X-Ray System) (K897115) received a 510(k) decision of Substantially Equivalent on March 13, 1990, 77 days after the submission was received.
What is the product code of K897115?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.