510(k) K191939
K191939 is an FDA 510(k) premarket notification submitted by Innocare Optoelectronics Corp. for the device "Yushan X-Ray Flat Panel Detector". The FDA issued a decision of Substantially Equivalent on August 29, 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. Innocare Optoelectronics Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2019
- Date Received
- July 19, 2019
- 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