510(k) K122495

PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR by Perkinelmer, Inc. — Product Code MQB

K122495 is an FDA 510(k) premarket notification submitted by Perkinelmer, Inc. for the device "PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR". The FDA issued a decision of Substantially Equivalent on November 28, 2012. 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. Perkinelmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2012
Date Received
August 16, 2012
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