Cleared Traditional

K232032 - PROBEAT-FR (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232032 · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Radiology device
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Jan 2024
Decision
189d
Days
Class 2
Risk

K232032 is an FDA 510(k) clearance for the PROBEAT-FR. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha (Kashiwa-Shi, JP). The FDA issued a Cleared decision on January 12, 2024 after a review of 189 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. Radiation Oncology Systems, Kashiwanoha devices

Submission Details

510(k) Number K232032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2023
Decision Date January 12, 2024
Days to Decision 189 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
82d slower than avg
Panel avg: 107d · This submission: 189d
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 90
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