Cleared Traditional

K181676 - Mini Ridge Filter and auxiliary functio...

K181676 is the FDA 510(k) clearance for Mini Ridge Filter and auxiliary functio... by Hitachi Ltd. Healthcare Hitachi Works. It is a Class 2 Radiology device (product code LHN) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K181676 · Hitachi Ltd. Healthcare Hitachi Works · Radiology device
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Aug 2018
Decision
51d
Days
Class 2
Risk

K181676 is an FDA 510(k) clearance for the Mini Ridge Filter and auxiliary functions for PROBEAT-V. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Hitachi Ltd. Healthcare Hitachi Works (Hitachi, JP). The FDA issued a Cleared decision on August 15, 2018 after a review of 51 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. Healthcare Hitachi Works devices

Submission Details

510(k) Number K181676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2018
Decision Date August 15, 2018
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
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 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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