GE Innova Solid State Xray Imager Flurosopic X Ray System
FDA 510(k) K113034 · GE Healthcare
510(k) numberK113034
Submission
- Device name
- GE Innova Solid State Xray Imager Flurosopic X Ray System
- Applicant
- GE Healthcare
Wauwatosa, WI, US - Received
- October 11, 2011
- Decision date
- December 13, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was GE Innova Solid State Xray Imager Flurosopic X Ray System cleared by the FDA?
GE Innova Solid State Xray Imager Flurosopic X Ray System (K113034) received a 510(k) decision of Substantially Equivalent on December 13, 2011, 63 days after the submission was received.
What is the product code of K113034?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.