Cleared Traditional

K150929 - CareView 1500Cw X-ray Flat Panel Detectors

K150929 is an FDA 510(k) clearance for CareView 1500Cw X-ray Flat Panel Detectors, manufactured by Careray Digital Medical System Co., Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K150929 · Careray Digital Medical System Co., Ltd. · Radiology device
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Aug 2015
Decision
120d
Days
Class 2
Risk

K150929 is an FDA 510(k) clearance for the CareView 1500Cw X-ray Flat Panel Detectors. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Careray Digital Medical System Co., Ltd. (Sunzhou, CN). The FDA issued a Cleared decision on August 4, 2015 after a review of 120 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 Careray Digital Medical System Co., Ltd. devices

FDA 510(k) Submission Details - K150929

510(k) Number K150929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2015
Decision Date August 04, 2015
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
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 264
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K150929.
FDR D-EVO GL Flat Panel Detector System
K152138 · Fujifilm Medical System U.S.A., Inc. · Nov 2015
EVS 3643
K151942 · DRTECH Corporation · Oct 2015
GR40CW
K152094 · Samsung Electronics Co., Ltd. · Oct 2015
AeroDR SYSTEM 2
K151465 · Konica Minolta, Inc. · Jun 2015
Carestream DRX-1 System
K150766 · Carestream Health, Inc. · Jun 2015
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
K150150 · Rayence Co., Ltd. · Mar 2015