510(k) K170480
K170480 is an FDA 510(k) premarket notification submitted by Shanghai PZ Medical Technolgoy Co., Ltd. for the device "Models 3543A, 4343A, 2929A and A843B". The FDA issued a decision of Substantially Equivalent on Jul 7, 2017. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 7, 2017
- Date Received
- Feb 16, 2017
- 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)