Panther TPS

GUDID 00868603000236

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.

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• Primary Device ID: 00868603000236
• NIH Device Record Key: e1476535-d19e-4188-9d29-3086d2e64dff
• Commercial Distribution Discontinuation: 2021-11-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panther TPS
• Version Model Number: version 5.51
• Company DUNS: 002162728
• Company Name: PROWESS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (925) 405-6556
• Email: support@prowess.com
• Phone: (925) 405-6556
• Email: support@prowess.com
• Phone: (925) 405-6556
• Email: support@prowess.com
• Phone: (925) 405-6556
• Email: support@prowess.com
• Phone: (925) 405-6556
• Email: support@prowess.com
• Phone: (925) 405-6556
• Email: support@prowess.com
• Phone: (925) 405-6556
• Email: support@prowess.com
• Phone: (925) 405-6556
• Email: support@prowess.com
• Phone: (925) 405-6556
• Email: support@prowess.com
• Phone: (925) 405-6556
• Email: support@prowess.com
• Phone: (925) 405-6556
• Email: support@prowess.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868603000236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032456

FDA Product Code

• MUJ: System,Planning,Radiation Therapy Treatment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-11

On-Brand Devices [Panther TPS]

• 00868603000236: The purpose of Prowess Panther TPS is to provide a complete program for radiation therapy treatm
• 00859032007132: 5.7
• 00859032007088: v5.61
• 00859032007064: v5.6