Cleared Traditional

SKR 3000

K241319 · Konica Minolta, Inc. · Radiology
Nov 2024
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K241319 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 November 21, 2024, 195 days after receiving the submission on May 10, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K241319 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2024
Decision Date November 21, 2024
Days to Decision 195 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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