Cleared Special

SKR 3000

K223267 · Konica Minolta, Inc. · Radiology
Nov 2022
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K223267 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. (Hino-Shi, JP). The FDA issued a Cleared decision on November 17, 2022, 24 days after receiving the submission on October 24, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K223267 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2022
Decision Date November 17, 2022
Days to Decision 24 days
Submission Type Special
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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