Cleared Traditional

K053280 - PROBEAT

K053280 is an FDA 510(k) clearance for PROBEAT, manufactured by Hitachi, Ltd., Power Systems Group. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K053280 · Hitachi, Ltd., Power Systems Group · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
106d
Days
Class 2
Risk

K053280 is an FDA 510(k) clearance for the PROBEAT. 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 March 9, 2006 after a review of 106 days - within the typical 510(k) review window.

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., Power Systems Group devices

FDA 510(k) Submission Details - K053280

510(k) Number K053280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2005
Decision Date March 09, 2006
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
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 45
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K053280.
PROTON THERAPY MULTILEAF COLLIMATOR
K093250 · Varian Medical Systems · Dec 2009
ATLAS-BASED AUTOSEGMENTATION
K080799 · Computerized Medical Systems, Inc. · Aug 2008
IPLAN RT IMAGE
K080886 · Brainlab AG · Jun 2008
INTUITION IMAGE
K032511 · Brainlab AG · Jan 2004
NORTHEAST PROTON THERAPY CENTER
K983332 · Massachusetts General Hospital · Jul 2001
PROTON THERAPY SYSTEM
K983024 · Ion Beam Applications S.A. · Jul 2001