Cleared Traditional

K150766 - Carestream DRX-1 System

K150766 is the FDA 510(k) clearance for Carestream DRX-1 System by Carestream Health, Inc.. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K150766 · Carestream Health, Inc. · Radiology device
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Jun 2015
Decision
92d
Days
Class 2
Risk

K150766 is an FDA 510(k) clearance for the Carestream DRX-1 System. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on June 24, 2015 after a review of 92 days - within the typical 510(k) review window.

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 Carestream Health, Inc. devices

Submission Details

510(k) Number K150766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2015
Decision Date June 24, 2015
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 218
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K150766.
Carestream DRX-1 System with DRX Plus 4343 Detectors
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GR40CW
K152094 · Samsung Electronics Co., Ltd. · Oct 2015
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
K150150 · Rayence Co., Ltd. · Mar 2015
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
K142003 · Fujifilm Medical System U.S.A., Inc. · Oct 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K141765 · Fujifilm Medical Systems U.S.A, Inc. · Oct 2014