Cleared Traditional

SKR 3000

K213908 · Konica Minolta, Inc. · Radiology
Jan 2022
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K213908 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 January 31, 2022, 48 days after receiving the submission on December 14, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K213908 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2021
Decision Date January 31, 2022
Days to Decision 48 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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