9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options
FDA 510(k) K061953 · Ge Oec Medical Systems
510(k) numberK061953
Submission
- Device name
- 9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options
- Applicant
- Ge Oec Medical Systems
Salt Lake City, UT, US - Received
- July 10, 2006
- Decision date
- August 15, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was 9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options cleared by the FDA?
9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options (K061953) received a 510(k) decision of Substantially Equivalent on August 15, 2006, 36 days after the submission was received.
What is the product code of K061953?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.