Cleared Traditional

K122616 - PANTHER OIS/R & V MODEL VERSION 2.0

K122616 is an FDA 510(k) clearance for PANTHER OIS/R & V MODEL VERSION 2.0, manufactured by Prowess, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K122616 · Prowess, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
116d
Days
Class 2
Risk

K122616 is an FDA 510(k) clearance for the PANTHER OIS/R & V MODEL VERSION 2.0. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Prowess, Inc. (Concord, US). The FDA issued a Cleared decision on December 21, 2012 after a review of 116 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 Prowess, Inc. devices

FDA 510(k) Submission Details - K122616

510(k) Number K122616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2012
Decision Date December 21, 2012
Days to Decision 116 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
9d slower than avg
Panel avg: 107d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, 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 - IYE Accelerator, Linear, Medical

All 332
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K122616.
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K130992 · Philips Medical Systems (Cleveland), Inc. · Jun 2013
COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV
K123812 · Siemens Medical Solutions USA, Inc. · Mar 2013
INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)
K123788 · Varian Medical Systems, Inc. · Jan 2013
TRUEBEAM
K123291 · Varian Medical Systems, Inc. · Dec 2012
CALYPSO SYSTEM
K123137 · Varian Medical Systems · Dec 2012
EXACTRAC VERO
K122451 · Brainlab AG · Sep 2012