Cleared Traditional

K161163 - PROBEAT-V Proton Beam Therapy System wi...

K161163 is the FDA 510(k) clearance for PROBEAT-V Proton Beam Therapy System wi... by Hitachi , Ltd.. It is a Class 2 Radiology device (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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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

Submission Details

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
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.

Device Classification

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 31
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