Cleared Traditional

K162504 - SKR 3000

K162504 is an FDA 510(k) clearance for SKR 3000, manufactured by Konica Minolta, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K162504 · Konica Minolta, Inc. · Radiology device
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Oct 2016
Decision
26d
Days
Class 2
Risk

K162504 is an FDA 510(k) clearance for the SKR 3000. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Konica Minolta, Inc. (Hino-Shi, JP). The FDA issued a Cleared decision on October 3, 2016 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Konica Minolta, Inc. devices

FDA 510(k) Submission Details - K162504

510(k) Number K162504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2016
Decision Date October 03, 2016
Days to Decision 26 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Storch Amini & Munves PC
RUSSELL D. MUNVES

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 259
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K162504.
EVS 3643, EVS 3643G
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1012WCC, 1012WGC
K162518 · Rayence Co., Ltd. · Oct 2016
1717WCC / 1717WGC
K162519 · Rayence Co., Ltd. · Oct 2016
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
K161368 · Agfa Healthcare N.V. · Sep 2016
SCATTER CORRECTION FOR CXDI SERIES
K153312 · Canon, Inc. · Jun 2016
FDR D-EVO flat Panel Detector System
K153464 · Fujifilm Medical Systems U.S.A, Inc. · Apr 2016