Cleared Traditional

K132919 - GANTRY BEAM LINE

K132919 is an FDA 510(k) clearance for GANTRY BEAM LINE, manufactured by Ion Beam Applications S.A.. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K132919 · Ion Beam Applications S.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
296d
Days
Class 2
Risk

K132919 is an FDA 510(k) clearance for the GANTRY BEAM LINE. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Ion Beam Applications S.A. (Philadelphia, US). The FDA issued a Cleared decision on July 10, 2014 after a review of 296 days - an extended review 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: 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 Ion Beam Applications S.A. devices

FDA 510(k) Submission Details - K132919

510(k) Number K132919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2013
Decision Date July 10, 2014
Days to Decision 296 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 107d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHN Device Classification - Class 2, Special Controls

Product Code LHN System, Radiation Therapy, Charged-particle, 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 - LHN System, Radiation Therapy, Charged-particle, Medical

All 76
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K132919.
PROBEAT-V
K152592 · Hitachi, Ltd., Health Care Company · Nov 2015
Extended Range Shifter for PROBEAT-V
K152207 · Hitachi, Ltd., Health Care Company · Oct 2015
PROBEAT-V
K151132 · Hitachi, Ltd., Health Care Company · Jun 2015
VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
K133914 · Medcom GmbH · Apr 2014
RADIANCE 330 PROTON THERAPY SYSTEM
K134052 · Protom International, Inc. · Mar 2014
PROBEAM PROTON THERAPY SYSTEM
K133191 · Varian Medical Systems · Jan 2014