Cleared Traditional

K101294 - PT2 VARIAN PROTON THERAPY SYSTEM

K101294 is an FDA 510(k) clearance for PT2 VARIAN PROTON THERAPY SYSTEM, manufactured by Varian Medical Systems, Oncology Systems. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K101294 · Varian Medical Systems, Oncology Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
231d
Days
Class 2
Risk

K101294 is an FDA 510(k) clearance for the PT2 VARIAN PROTON THERAPY SYSTEM. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Varian Medical Systems, Oncology Systems (Palo Alto, US). The FDA issued a Cleared decision on December 27, 2010 after a review of 231 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.

FDA 510(k) Submission Details - K101294

510(k) Number K101294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2010
Decision Date December 27, 2010
Days to Decision 231 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
124d slower than avg
Panel avg: 107d · This submission: 231d
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 90
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K101294.
AIR-BAG SYSTEM
K112969 · Niigata Mechatronics Co., Ltd. · Mar 2012
SUN 125C IONIZATION CHAMBER
K112981 · Sun Nuclear Corp. · Jan 2012
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
K112768 · Calypso Medical Technologies, Inc. · Nov 2011
CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
K102373 · Calypso Medical Technologies, Inc. · Sep 2010
MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
K101508 · Ion Beam Applications S.A. · Aug 2010
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
K100766 · Ion Beam Applications S.A. · Jul 2010
K101294 · PT2 VARIAN PROTON THERAPY SYSTEM
Download PDF FDA Summary Varian Medical System…