Cleared Traditional

INTEGRA IMMOBILIZATION SYSTEM (K050888) - FDA 510(k) Clearance

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

K050888 · Diacor, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
46d
Days
Class 2
Risk

K050888 is an FDA 510(k) clearance for the INTEGRA IMMOBILIZATION SYSTEM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Diacor, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 23, 2005 after a review of 46 days - a notably fast clearance cycle.

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: 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 Diacor, Inc. devices

Submission Details

510(k) Number K050888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2005
Decision Date May 23, 2005
Days to Decision 46 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 107d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K050888.
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