Cleared Special

K073059 - PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM

K073059 is an FDA 510(k) clearance for PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM, manufactured by Hitachi, Ltd., Power Systems Group. The device is a Class 2 Radiology device with product code LHN cleared through the Special 510(k) pathway after a 41-day FDA review.

K073059 · Hitachi, Ltd., Power Systems Group · Radiology device
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Dec 2007
Decision
41d
Days
Class 2
Risk

K073059 is an FDA 510(k) clearance for the PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Hitachi, Ltd., Power Systems Group (Washington, US). The FDA issued a Cleared decision on December 10, 2007 after a review of 41 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hitachi, Ltd., Power Systems Group devices

FDA 510(k) Submission Details - K073059

510(k) Number K073059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2007
Decision Date December 10, 2007
Days to Decision 41 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

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

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