PROWESS, INC.

Address:1844 Clayton Road,Concord,CA,94520,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Planning, Radiation Therapy Treatment (MUJ) (5) Accelerator, Linear, Medical (IYE) (2) System,Planning,Radiation Therapy Treatment (MUJ) (2)

Premarket Exempt

Clear

Panther Brachy - 00859032007002 Catalog Number :

Device Class : 2

Duns Number: 002162728

Premarket Exempt : No

Product Code : MUJ

Prescription Use : No

Device Count : 1

Panther TPS - 00859032007064 Catalog Number :

Device Class : 2

Duns Number: 002162728

Premarket Exempt : No

Product Code : MUJ

Prescription Use : No

Device Count : 1

Panther TPS - 00859032007088 Catalog Number :

Device Class : 2

Duns Number: 002162728

Premarket Exempt : No

Product Code : MUJ

Prescription Use : No

Device Count : 1

Panther OIS R&V - 00859032007095 Catalog Number :

Device Class : 2

Duns Number: 002162728

Premarket Exempt : No

Product Code : IYE, MUJ

Prescription Use : No

Device Count : 1

Panther TPS - 00859032007132 Catalog Number :

Device Class : 2

Duns Number: 002162728

Premarket Exempt : No

Product Code : MUJ

Prescription Use : No

Device Count : 1

Panther OIS - 00859032007156 Catalog Number :

Device Class : 2

Duns Number: 002162728

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Panther TPS - 00868603000236 Catalog Number :

Device Description : The purpose of Prowess Panther TPS is to provide a complete program for radiatio 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.

Device Class : 2

Duns Number: 002162728

Premarket Exempt : No

Product Code : MUJ

Prescription Use : No

Device Count : 1

Panther Brachy - 01868603000212 Catalog Number :

Device Class : 2

Duns Number: 002162728

Premarket Exempt : No

Product Code : MUJ

Prescription Use : No

Device Count : 1

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