Sony Cardiac Analysis and Review Station (Cars)
FDA 510(k) K931170 · Sony Medical Systems
510(k) numberK931170
Submission
- Device name
- Sony Cardiac Analysis and Review Station (Cars)
- Applicant
- Sony Medical Systems
North Attleboro, MA, US - Received
- March 8, 1993
- Decision date
- June 14, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Sony Cardiac Analysis and Review Station (Cars) cleared by the FDA?
Sony Cardiac Analysis and Review Station (Cars) (K931170) received a 510(k) decision of Substantially Equivalent on June 14, 1993, 98 days after the submission was received.
What is the product code of K931170?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.