Cleared Traditional

K083502 - PANTHER REALART

K083502 is an FDA 510(k) clearance for PANTHER REALART, manufactured by Prowess, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K083502 · Prowess, Inc. · Radiology device
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May 2009
Decision
161d
Days
Class 2
Risk

K083502 is an FDA 510(k) clearance for the PANTHER REALART, MODEL 4.7. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Prowess, Inc. (Concord, US). The FDA issued a Cleared decision on May 5, 2009 after a review of 161 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 Prowess, Inc. devices

FDA 510(k) Submission Details - K083502

510(k) Number K083502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2008
Decision Date May 05, 2009
Days to Decision 161 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
54d slower than avg
Panel avg: 107d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
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 - MUJ System, Planning, Radiation Therapy Treatment

All 145
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K083502.
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K080888 · Brainlab AG · Jun 2008
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K073020 · Varian Medical Systems, Inc. · Dec 2007