Cleared Traditional

SKR 3000

K250665 · Konica Minolta, Inc. · Radiology
Jun 2025
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K250665 is an FDA 510(k) clearance for the SKR 3000, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Konica Minolta, Inc. (Tokyo, JP). The FDA issued a Cleared decision on June 17, 2025, 104 days after receiving the submission on March 5, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K250665 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2025
Decision Date June 17, 2025
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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