510(k) K252996

Universal 1417PI by Konica Minolta Healthcare Americas, Inc. — Product Code MQB

K252996 is an FDA 510(k) premarket notification submitted by Konica Minolta Healthcare Americas, Inc. for the device "Universal 1417PI". The FDA issued a decision of Substantially Equivalent on June 12, 2026. 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 Healthcare Americas, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2026
Date Received
September 18, 2025
Clearance Type
Abbreviated
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