Cleared Traditional

K152207 - Extended Range Shifter for PROBEAT-V

K152207 is an FDA 510(k) clearance for Extended Range Shifter for PROBEAT-V, manufactured by Hitachi, Ltd., Health Care Company. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K152207 · Hitachi, Ltd., Health Care Company · Radiology device
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Oct 2015
Decision
57d
Days
Class 2
Risk

K152207 is an FDA 510(k) clearance for the Extended Range Shifter for PROBEAT-V. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Hitachi, Ltd., Health Care Company (Tokyo, JP). The FDA issued a Cleared decision on October 2, 2015 after a review of 57 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., Health Care Company devices

FDA 510(k) Submission Details - K152207

510(k) Number K152207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2015
Decision Date October 02, 2015
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
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 89
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