Optima XR646 HD
FDA 510(k) K173612 · Ge Hualun Medical Systems Co. , Ltd.
510(k) numberK173612
Submission
- Device name
- Optima XR646 HD
- Applicant
- Ge Hualun Medical Systems Co. , Ltd.
Beijing, CN - Received
- November 22, 2017
- Decision date
- December 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Optima XR646 HD cleared by the FDA?
Optima XR646 HD (K173612) received a 510(k) decision of Substantially Equivalent on December 11, 2017, 19 days after the submission was received.
What is the product code of K173612?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.