The Ic-Pro System, Model Version 3.2
FDA 510(k) K083745 · Paieon, Inc.
510(k) numberK083745
Submission
- Device name
- The Ic-Pro System, Model Version 3.2
- Applicant
- Paieon, Inc.
Rosh Haayin, IL - Received
- December 16, 2008
- Decision date
- February 17, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was The Ic-Pro System, Model Version 3.2 cleared by the FDA?
The Ic-Pro System, Model Version 3.2 (K083745) received a 510(k) decision of Substantially Equivalent on February 17, 2009, 63 days after the submission was received.
What is the product code of K083745?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.