510(k) K172435
K172435 is an FDA 510(k) premarket notification submitted by Medien International Co, Ltd. for the device "Galaxy R Digital Radiography Upgrade". The FDA issued a decision of Substantially Equivalent on Oct 13, 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. Medien International Co, Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 13, 2017
- Date Received
- Aug 11, 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)