Cleared Traditional

K043062 - MODEL SR-130-D PORTABLE DIGITAL X-RAY S...

K043062 is the FDA 510(k) clearance for MODEL SR-130-D PORTABLE DIGITAL X-RAY S... by Source-Ray, Inc.. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K043062 · Source-Ray, Inc. · Radiology device
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Dec 2004
Decision
38d
Days
Class 2
Risk

K043062 is an FDA 510(k) clearance for the MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM. 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 December 13, 2004 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Source-Ray, Inc. devices

Submission Details

510(k) Number K043062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2004
Decision Date December 13, 2004
Days to Decision 38 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
69d faster than avg
Panel avg: 107d · This submission: 38d
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 K043062.
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