Cleared Traditional

ALIGNRT (K052682) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052682 · Vision RT Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 165
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K052682.
ARTISTE MV SA
K072485 · Siemens Medical Solutions USA, Inc. · Dec 2007
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0
K060633 · Siemens Medical Solutions USA, Inc. · May 2006
ONCOR EXPRESSION
K060226 · Siemens Medical Solutions USA, Inc. · Mar 2006
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
K031764 · Siemens Medical Solutions USA, Inc. · Sep 2003
PRIMUS
K993425 · Siemens Medical Solutions USA, Inc. · Nov 1999
GENESIS IMRT LINEAR ACCELERATOR
K982502 · Siemens Medical Solutions USA, Inc. · Jul 1998