510(k) K160204
K160204 is an FDA 510(k) premarket notification submitted by Bontech, Inc. for the device "BSD4343 Digital Flat Panel X-ray Detector". The FDA issued a decision of Substantially Equivalent on Jun 9, 2016. 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. Bontech, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 9, 2016
- Date Received
- Jan 28, 2016
- 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)