510(k) K213646
K213646 is an FDA 510(k) premarket notification submitted by Iray Technology Taicang , Ltd. for the device "Focus HD 35 Detector". The FDA issued a decision of Substantially Equivalent on Mar 29, 2022. 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. Iray Technology Taicang , Ltd. has 20 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 29, 2022
- Date Received
- Nov 4, 2021
- 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
- 510(k)