Cleared Traditional

K130464 - CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR

K130464 is an FDA 510(k) clearance for CARESTREAM DRX-1 SYSTEM WITH DRX 2530C ..., manufactured by Carestream Health, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K130464 · Carestream Health, Inc. · Radiology device
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Jun 2013
Decision
105d
Days
Class 2
Risk

K130464 is an FDA 510(k) clearance for the CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR. 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 7, 2013 after a review of 105 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

FDA 510(k) Submission Details - K130464

510(k) Number K130464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2013
Decision Date June 07, 2013
Days to Decision 105 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
2d faster than avg
Panel avg: 107d · This submission: 105d
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 395
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K130464.
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
K130935 · Rayence Co., Ltd. · Jul 2013
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
K131314 · Swissray Medical AG · Jun 2013
DR LONG LENGTH IMAGING SOFTWARE
K130567 · Carestream Health, Inc. · Jun 2013
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K130377 · Medicatech USA · May 2013
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
K130883 · Sedecal., Sa. · Apr 2013
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
K123345 · Rayence Co., Ltd. · Mar 2013