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PROWESS, INC.

Matched from indexed company URL: Prowess, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29392482939248PROWESS, INC.1N2026-01-015129 Commercial Circle Concord CA US 94520

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
393351369663547K984196MODIFICATION TO PROWESS PRO-SIMMUJ1998-12-11
393351991594136K211760Panther OISIYE2021-09-28
393351723610387K193459Panther StereotacticMUJ2020-04-27
393351667212645K143514Panther StereoSeedMUJ2015-12-11
393351130693416K122616PANTHER OIS/R & V MODEL VERSION 2.0IYE2012-12-21
393351830447056K101076PROWESS PANTHER PROARC, MODEL VERSION 5.0MUJ2010-07-27
393351582747343K100801PUMA MODEL VERSION 1.0IYE2010-06-18
393351166814103K083502PANTHER REALART, MODEL 4.7MUJ2009-05-05
393351797867658K032456PROWESSMUJ2003-10-16
393351578518049
393351983509505

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MUJ112020-04-27
IYE52021-09-28

PMN#

GUDID#

Panther TPS - The purpose of Prowess Panther TPS is to provide a complete program for radiation therapy treatment planning. This includes computation, display, evaluation, and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The device provides data in the form of display, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. Panther treatment planning system allows radiation physicians, physicists, and dosimetrists to optimize the delivery of radiation in treating cancer and related diseases.

Prowess, Inc.

2017-01-11