Cleared Traditional

K062472 - OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115

K062472 is an FDA 510(k) clearance for OPTIONAL REMOTE CONTROL, manufactured by Source-Ray, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K062472 · Source-Ray, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
68d
Days
Class 2
Risk

K062472 is an FDA 510(k) clearance for the OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115. 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 October 31, 2006 after a review of 68 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

FDA 510(k) Submission Details - K062472

510(k) Number K062472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date October 31, 2006
Days to Decision 68 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 107d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

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 175
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K062472.
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
AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
K063262 · Virtual Imaging · Dec 2006
PULSERA
K061685 · Philips Medical Systems North America Co. · Sep 2006
MINXRAY, MODELS HFP24 AND HFP40
K060566 · Mikasa X-Ray Co., Ltd. · Apr 2006
GE DEFINIUM AMX 700, MODEL AMX 700
K052897 · General Electric Medical Systems · Nov 2005