Cleared Traditional

K171049 - Real Time Image Gating System for Proton Beam Therapy Systems

K171049 is an FDA 510(k) clearance for Real Time Image Gating System for Proto..., manufactured by Hitachi, Ltd. Healthcare. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K171049 · Hitachi, Ltd. Healthcare · Radiology device
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Dec 2017
Decision
263d
Days
Class 2
Risk

K171049 is an FDA 510(k) clearance for the Real Time Image Gating System for Proton Beam Therapy Systems. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Hitachi, Ltd. Healthcare (Tokyo, JP). The FDA issued a Cleared decision on December 26, 2017 after a review of 263 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 Hitachi, Ltd. Healthcare devices

FDA 510(k) Submission Details - K171049

510(k) Number K171049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2017
Decision Date December 26, 2017
Days to Decision 263 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
156d slower than avg
Panel avg: 107d · This submission: 263d
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

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