510(k) K181526
K181526 is an FDA 510(k) premarket notification submitted by Varex Imaging Corporation for the device "XRpad2 4343 HWC-M Flat Panel Detector". The FDA issued a decision of Substantially Equivalent on July 3, 2018. 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. Varex Imaging Corporation has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2018
- Date Received
- June 11, 2018
- Clearance Type
- Special
- 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