Cleared Traditional

K031385 - ANZAI AZ-733 RESPIRATORY GATING SYSTEM

K031385 is the FDA 510(k) clearance for ANZAI AZ-733 RESPIRATORY GATING SYSTEM by Anzai Medical Co., Ltd.. It is a Class 2 Radiology device (product code LHN) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K031385 · Anzai Medical Co., Ltd. · Radiology device
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Nov 2003
Decision
193d
Days
Class 2
Risk

K031385 is an FDA 510(k) clearance for the ANZAI AZ-733 RESPIRATORY GATING SYSTEM. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Anzai Medical Co., Ltd. (Brookeville, US). The FDA issued a Cleared decision on November 10, 2003 after a review of 193 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 Anzai Medical Co., Ltd. devices

Submission Details

510(k) Number K031385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2003
Decision Date November 10, 2003
Days to Decision 193 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
86d slower than avg
Panel avg: 107d · This submission: 193d
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

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