510(k) K192400
K192400 is an FDA 510(k) premarket notification submitted by DRTECH Corporation for the device "EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG". The FDA issued a decision of Substantially Equivalent on October 3, 2019. 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. DRTECH Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2019
- Date Received
- September 3, 2019
- 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