Cleared Traditional

K052001 - MODEL SR-115 PORTABLE X-RAY SYSTEM

K052001 is the FDA 510(k) clearance for MODEL SR-115 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 17-day FDA review.

K052001 · Source-Ray, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
17d
Days
Class 2
Risk

K052001 is an FDA 510(k) clearance for the MODEL SR-115 PORTABLE 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 August 11, 2005 after a review of 17 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 K052001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2005
Decision Date August 11, 2005
Days to Decision 17 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
90d faster than avg
Panel avg: 107d · This submission: 17d
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 K052001.
FCR GO PORTABLE DIGITAL X-RAY SYSTEM
K080945 · Fujifilm Medical Systems U.S.A, Inc. · Apr 2008
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K072392 · Siemens Medical Solutions USA, Inc. · Sep 2007
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K071015 · Siemens Medical Solutions USA, Inc. · May 2007
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · General Electric Co. · Jul 2004
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
K041763 · Shimadzu Corp. · Jul 2004
3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
K022337 · Siemens Medical Solutions USA, Inc. · Aug 2002