Cleared Traditional

K161163 - PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory

K161163 is an FDA 510(k) clearance for PROBEAT-V Proton Beam Therapy System wi..., manufactured by Hitachi , Ltd.. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K161163 · Hitachi , Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2016
Decision
79d
Days
Class 2
Risk

K161163 is an FDA 510(k) clearance for the PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Hitachi , Ltd. (Tokyo, JP). The FDA issued a Cleared decision on July 13, 2016 after a review of 79 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 Hitachi , Ltd. devices

FDA 510(k) Submission Details - K161163

510(k) Number K161163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2016
Decision Date July 13, 2016
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
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

Hogan Lovells US LLP
Jonathan Kahan

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 67
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K161163.
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