Cleared Traditional

K160612 - Sumitomo Proton Therapy System

K160612 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 167-day FDA review.

K160612 · Sumitomo Heavy Industries, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
167d
Days
Class 2
Risk

K160612 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. (Niihama, JP). The FDA issued a Cleared decision on August 17, 2016 after a review of 167 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 - K160612

510(k) Number K160612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2016
Decision Date August 17, 2016
Days to Decision 167 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
60d slower than avg
Panel avg: 107d · This submission: 167d
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 Consultant

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CYNTHIA NOLTE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K160612.
IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
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ProNova SC360 Proton Therapy System
K162246 · Pronova Solutions, LLC · Dec 2016
Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
K152224 · Ion Beam Application S.A. · Aug 2016
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
K161163 · Hitachi , Ltd. · Jul 2016
Anzai Respiratory Gating System
K160432 · Anzai Medical Co., Ltd. · Apr 2016