510(k) K140771

PHILIPS ELEVA WORKSPOT by Philips Medical Systems Dmc GmbH — Product Code MQB

K140771 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "PHILIPS ELEVA WORKSPOT". The FDA issued a decision of Substantially Equivalent on April 25, 2014. 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. Philips Medical Systems Dmc GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2014
Date Received
March 27, 2014
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