Cleared Traditional

K052682 - ALIGNRT

K052682 is an FDA 510(k) clearance for ALIGNRT, manufactured by Vision RT Limited. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K052682 · Vision RT Limited · Radiology device
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Jan 2006
Decision
100d
Days
Class 2
Risk

K052682 is an FDA 510(k) clearance for the ALIGNRT. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Vision RT Limited (London, GB). The FDA issued a Cleared decision on January 6, 2006 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Vision RT Limited devices

FDA 510(k) Submission Details - K052682

510(k) Number K052682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2005
Decision Date January 06, 2006
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 107d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 367
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K052682.
MIGUE
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VISION (WITH OFF-LINE REVIEW)
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NAVIGATOR
K042875 · Nomos Corp. · Jul 2005