Cleared Traditional

K163624 - Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)

K163624 is an FDA 510(k) clearance for Dynamic Visualization II Image Processi..., manufactured by Fujifilm Medical Systems U.S.A, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K163624 · Fujifilm Medical Systems U.S.A, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
190d
Days
Class 2
Risk

K163624 is an FDA 510(k) clearance for the Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID30.... Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Stamford, US). The FDA issued a Cleared decision on June 30, 2017 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujifilm Medical Systems U.S.A, Inc. devices

FDA 510(k) Submission Details - K163624

510(k) Number K163624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2016
Decision Date June 30, 2017
Days to Decision 190 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
83d slower than avg
Panel avg: 107d · This submission: 190d
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 Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 386
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K163624.
SKR 3000
K171716 · Konica Minolta, Inc. · Aug 2017
Models 3543A, 4343A, 2929A and A843B
K170480 · Shanghai PZ Medical Technolgoy Co., Ltd. · Jul 2017
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
K171461 · Philips Medical Systems Dmc GmbH · Jul 2017
BSD4343R Digital Flat Panel X-ray Detector
K171485 · Bontech, Inc. · Jun 2017
1417WGC_127um and 1417WGC_140um
K171417 · Rayence Co., Ltd. · Jun 2017
1417WCC_127um and1417WCC_140um
K171418 · Rayence Co., Ltd. · Jun 2017