510(k) K173612
K173612 is an FDA 510(k) premarket notification submitted by Ge Hualun Medical Systems Co. , Ltd. for the device "Optima XR646 HD". The FDA issued a decision of Substantially Equivalent on December 11, 2017. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Ge Hualun Medical Systems Co. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2017
- Date Received
- November 22, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type