Vanguard XR-350 Cineangiogram Projector
FDA 510(k) K953563 · Jamieson Film Co.
510(k) numberK953563
Submission
- Device name
- Vanguard XR-350 Cineangiogram Projector
- Applicant
- Jamieson Film Co.
Dallas, TX, US - Received
- July 31, 1995
- Decision date
- October 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vanguard XR-350 Cineangiogram Projector cleared by the FDA?
Vanguard XR-350 Cineangiogram Projector (K953563) received a 510(k) decision of Substantially Equivalent on October 5, 1995, 66 days after the submission was received.
What is the product code of K953563?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.