Cleared Traditional

K171085 - GMR40

K171085 is an FDA 510(k) clearance for GMR40, manufactured by Neurologica Corporation, A Subsidiary OF. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K171085 · Neurologica Corporation, A Subsidiary OF · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
29d
Days
Class 2
Risk

K171085 is an FDA 510(k) clearance for the GMR40. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Neurologica Corporation, A Subsidiary OF (Danvers, US). The FDA issued a Cleared decision on May 11, 2017 after a review of 29 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 Neurologica Corporation, A Subsidiary OF devices

FDA 510(k) Submission Details - K171085

510(k) Number K171085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2017
Decision Date May 11, 2017
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
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 285
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K171085.
1717SGC_127um and 1717SGC_140um
K171419 · Rayence Co., Ltd. · Jun 2017
1717SCC_127um and 1717SCC_140um
K171420 · Rayence Co., Ltd. · Jun 2017
EVS 2430W, EVS 2430GW
K171137 · DRTECH Corporation · May 2017
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
K170332 · Canon, Inc. · Mar 2017
Aquarius 8600
K170202 · Imaging Dynamics Company , Ltd. · Feb 2017
pixium 4343RCE
K170113 · Philips Medical Systems Dmc GmbH · Feb 2017