Cleared Traditional

K090655 - PORTABLE X-RAY SYSTEM

K090655 is the FDA 510(k) clearance for PORTABLE X-RAY SYSTEM by Source-Ray, Inc.. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K090655 · Source-Ray, Inc. · Radiology device
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Jul 2009
Decision
125d
Days
Class 2
Risk

K090655 is an FDA 510(k) clearance for the PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Source-Ray, Inc. (Bohemia, US). The FDA issued a Cleared decision on July 14, 2009 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Source-Ray, Inc. devices

Submission Details

510(k) Number K090655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2009
Decision Date July 14, 2009
Days to Decision 125 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 118
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K090655.
DRX-REVOLUTION MOBILE X-RAY SYSTEM
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K090268 · Shimadzu Corp. · Jun 2009
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
K080701 · Shimadzu Corp. · May 2008
FCR GO PORTABLE DIGITAL X-RAY SYSTEM
K080945 · Fujifilm Medical Systems U.S.A, Inc. · Apr 2008