Cleared Traditional

K232032 - PROBEAT-FR

K232032 is an FDA 510(k) clearance for PROBEAT-FR, manufactured by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 189-day FDA review.

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

FDA 510(k) Submission Details - K232032

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.

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 Peers - LHN System, Radiation Therapy, Charged-particle, Medical

All 35
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K232032.
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K231863 · Varian Medical Systems, Inc. · Oct 2023
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Small Field Applicator
K220883 · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Dec 2022