Cleared Traditional

K143514 - Panther StereoSeed

K143514 is an FDA 510(k) clearance for Panther StereoSeed, 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 365-day FDA review.

K143514 · Prowess, Inc. · Radiology device
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Dec 2015
Decision
365d
Days
Class 2
Risk

K143514 is an FDA 510(k) clearance for the Panther StereoSeed. 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 December 11, 2015 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K143514

510(k) Number K143514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2014
Decision Date December 11, 2015
Days to Decision 365 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
258d slower than avg
Panel avg: 107d · This submission: 365d
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 K143514.
Eclipse Treatment Planning System
K170969 · Varian Medical Systems, Inc. · Jul 2017
Pinnacle Radiation Therapy Planning System
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syngo.via RT Image Suite
K162370 · Siemens Medical Solutions USA, Inc. · Oct 2016
Eclipse Treatment Planning System
K152393 · Varian Medical Systems, Inc. · Sep 2015
syngo VSim
K151887 · Siemens Medical Solutions USA, Inc. · Sep 2015
Leksell GammaPlan
K151666 · Elekta Instrument AB · Sep 2015