510(k) K070528
K070528 is an FDA 510(k) premarket notification submitted by Philips Medical Systems GmbH, Dmc for the device "PHILIPS ESSENTA DR". The FDA issued a decision of Substantially Equivalent on March 9, 2007. 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
- March 9, 2007
- Date Received
- February 23, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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