Digital Angiography System Digitex Safire
FDA 510(k) K032443 · Shimadzu Corp.
510(k) numberK032443
Submission
- Device name
- Digital Angiography System Digitex Safire
- Applicant
- Shimadzu Corp.
Torrance, CA, US - Received
- August 8, 2003
- Decision date
- February 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Digital Angiography System Digitex Safire cleared by the FDA?
Digital Angiography System Digitex Safire (K032443) received a 510(k) decision of Substantially Equivalent on February 20, 2004, 196 days after the submission was received.
What is the product code of K032443?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.