Cleared Traditional

K130567 - DR LONG LENGTH IMAGING SOFTWARE

K130567 is the FDA 510(k) clearance for DR LONG LENGTH IMAGING SOFTWARE by Carestream Health, Inc.. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K130567 · Carestream Health, Inc. · Radiology device
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Jun 2013
Decision
99d
Days
Class 2
Risk

K130567 is an FDA 510(k) clearance for the DR LONG LENGTH IMAGING SOFTWARE. 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 11, 2013 after a review of 99 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 K130567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date June 11, 2013
Days to Decision 99 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
8d faster than avg
Panel avg: 107d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01592435 Completed Observational Industry-sponsored

Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol

Carestream Digital Radiography Long Length Imaging Manual Stitch Editor Software Data Collection

76
Patients (actual)
2
Sites
Condition studied Spinal Injuries
Eligibility All sexes · Healthy volunteers accepted
Principal investigator Larry Kirshner, BSRT
Sponsor Carestream Health, Inc. (industry)
Started 2011-04-01 → Primary completion 2012-12-01
Primary outcome
Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate)
View full study on ClinicalTrials.gov

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 K130567.
DIGITAL FLAT PANEL X-RAY DETECTOR
K131114 · Rayence Co., Ltd. · Sep 2013
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,
K131106 · Canon, Inc. · Jul 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
K130935 · Rayence Co., Ltd. · Jul 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
K130464 · Carestream Health, Inc. · Jun 2013
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
K123345 · Rayence Co., Ltd. · Mar 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
K122928 · Rayence Co., Ltd. · Jan 2013