Panther TPS

Primary DI
00868603000236
Brand
Panther TPS
Company
Prowess, Inc.
Model
version 5.51
Device description
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.
Published
2017-01-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUJSystem,Planning,Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032456000
K083502000
K101076000
K984196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032456000PROWESSProwess, Inc.2003-10-16MUJ
K083502000PANTHER REALART, MODEL 4.7Prowess, Inc.2009-05-05MUJ
K101076000PROWESS PANTHER PROARC, MODEL VERSION 5.0Prowess, Inc.2010-07-27MUJ
K984196000MODIFICATION TO PROWESS PRO-SIMSsgi Prowess Systems1998-12-11MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868603000236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868603000236008686030002368686030002360868603000236

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(925) 405-6556support@prowess.com

Regulatory Flags#

DUNS number
002162728
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859032007316Panther TPS6.12026-06-01
00859032007323Panther TPS6.22026-06-01
00859032007330Panther OIS3.32026-06-01
00859032007347Panther TPS6.212026-06-01
00859032007354Panther OIS3.312026-06-01
00859032007088Panther TPSv5.612021-11-01
00859032007095Panther OIS R&Vv2.312021-11-01
00859032007033Panther OIS R&V2.22024-12-19
00859032007170Panther TPS5.72024-12-19
00859032007194Panther TPS5.72024-12-19
00859032007200Panther TPS5.82024-12-19
00859032007224Panther OIS3.12024-12-19
00859032007231Panther TPS5.812024-12-19
00859032007248Panther OIS3.112024-12-19
00859032007255Panther TPS5.92024-12-19
00859032007262Panther OIS3.122024-12-19
00859032007279Panther TPS6.02024-12-19
00859032007309Panther OIS3.22024-12-19
00859032007064Panther TPSv5.62021-11-01
01868603000212Panther Brachyversion 5.02017-04-28

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Primary DI, Brand, Company table
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00859032007347Panther TPSProwess, Inc.MUJ2026-06-01
00859032007354Panther OISProwess, Inc.MUJ2026-06-01
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