Cleared Traditional

SKR 4000

K191645 · Konica Minolta, Inc. · Radiology
Aug 2019
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K191645 is an FDA 510(k) clearance for the SKR 4000, 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 August 16, 2019, 58 days after receiving the submission on June 19, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K191645 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2019
Decision Date August 16, 2019
Days to Decision 58 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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