510(k) K202995
K202995 is an FDA 510(k) premarket notification submitted by Careray Digital Medical System Co., Ltd. for the device "X-ray Flat Panel Detectors/CareView 3600RF". The FDA issued a decision of Substantially Equivalent on Feb 19, 2021. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Careray Digital Medical System Co., Ltd. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 19, 2021
- Date Received
- Oct 1, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type
- 510(k)