Cleared Traditional

K032456 - PROWESS

K032456 is an FDA 510(k) clearance for PROWESS, 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 66-day FDA review.

K032456 · Prowess, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
66d
Days
Class 2
Risk

K032456 is an FDA 510(k) clearance for the PROWESS. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Prowess, Inc. (Chico, US). The FDA issued a Cleared decision on October 16, 2003 after a review of 66 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Prowess, Inc. devices

FDA 510(k) Submission Details - K032456

510(k) Number K032456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2003
Decision Date October 16, 2003
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
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 K032456.
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
K042269 · Elekta Instrument AB · Sep 2004
ECLIPSE WITH AAA
K041403 · Varian Medical Systems · Jul 2004
ONCENTRA-VISIR
K041719 · Nucletron Corp. · Jul 2004
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724 · Adac Laboratories · Oct 2003
OTP 1.2
K031349 · Nucletron Corp. · Aug 2003
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036 · Siemens Medical Solutions USA, Inc. · Nov 2002