Cleared Traditional

K130426 - SUMITOMO PROTON THERAPY SYSTEM

K130426 is an FDA 510(k) clearance for SUMITOMO PROTON THERAPY SYSTEM, manufactured by Sumitomo Heavy Industries, Ltd.. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K130426 · Sumitomo Heavy Industries, Ltd. · Radiology device
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Nov 2013
Decision
272d
Days
Class 2
Risk

K130426 is an FDA 510(k) clearance for the SUMITOMO PROTON THERAPY SYSTEM. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Sumitomo Heavy Industries, Ltd. (San Diego, US). The FDA issued a Cleared decision on November 19, 2013 after a review of 272 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 Sumitomo Heavy Industries, Ltd. devices

FDA 510(k) Submission Details - K130426

510(k) Number K130426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2013
Decision Date November 19, 2013
Days to Decision 272 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
165d slower than avg
Panel avg: 107d · This submission: 272d
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

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