Discovery XR656 HD with VolumeRad
FDA 510(k) K191699 · Ge Hualun Medical Systems Co. , Ltd.
510(k) numberK191699
Submission
- Device name
- Discovery XR656 HD with VolumeRad
- Applicant
- Ge Hualun Medical Systems Co. , Ltd.
Beijing, CN - Received
- June 25, 2019
- Decision date
- July 24, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Discovery XR656 HD with VolumeRad cleared by the FDA?
Discovery XR656 HD with VolumeRad (K191699) received a 510(k) decision of Substantially Equivalent on July 24, 2019, 29 days after the submission was received.
What is the product code of K191699?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.