Panther StereoSeed

System, Planning, Radiation Therapy Treatment

PROWESS, INC.

The following data is part of a premarket notification filed by Prowess, Inc. with the FDA for Panther Stereoseed.

Pre-market Notification Details

Device IDK143514
510k NumberK143514
Device Name:Panther StereoSeed
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant PROWESS, INC. 1844 CLAYTON ROAD Concord,  CA  94520
ContactRachel Scarano
CorrespondentRachel Scarano
PROWESS, INC. 1844 CLAYTON ROAD Concord,  CA  94520
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-11
Decision Date2015-12-11
Summary:summary

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