510(k) K250665

SKR 3000 by Konica Minolta, Inc. — Product Code MQB

K250665 is an FDA 510(k) premarket notification submitted by Konica Minolta, Inc. for the device "SKR 3000". The FDA issued a decision of Substantially Equivalent on June 17, 2025. 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. Konica Minolta, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2025
Date Received
March 5, 2025
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