510(k) K220149
K220149 is an FDA 510(k) premarket notification submitted by Xera Medical Systems & Technology , Ltd. for the device "General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)". The FDA issued a decision of Substantially Equivalent on Apr 19, 2022. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 19, 2022
- Date Received
- Jan 19, 2022
- Clearance Type
- Traditional
- 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
- 510(k)