Angiographic System
FDA 510(k) K944952 · Acoma Medical Imaging, Inc.
510(k) numberK944952
Submission
- Device name
- Angiographic System
- Applicant
- Acoma Medical Imaging, Inc.
Wheeling, IL, US - Received
- October 7, 1994
- Decision date
- February 17, 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 Angiographic System cleared by the FDA?
Angiographic System (K944952) received a 510(k) decision of Substantially Equivalent on February 17, 1995, 133 days after the submission was received.
What is the product code of K944952?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.