Panther Brachy

GUDID 00859032007002

PROWESS, INC.

Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software

• Primary Device ID: 00859032007002
• NIH Device Record Key: c528ff54-ce75-4408-a4b3-418b5f9f9268
• Commercial Distribution Discontinuation: 2023-12-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panther Brachy
• Version Model Number: version 5.0
• 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
• 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	00859032007002 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-12
• Device Publish Date: 2018-06-11

Devices Manufactured by PROWESS, INC.

• 00859032007156 - Panther OIS: 2022-03-24
• 00859032007064 - Panther TPS: 2021-11-09
• 00859032007088 - Panther TPS: 2021-11-09
• 00859032007095 - Panther OIS|R&V: 2021-11-09
• 00859032007132 - Panther TPS: 2021-11-09
• 00859032007002 - Panther Brachy: 2018-07-12
• 00859032007002 - Panther Brachy: 2018-07-12
• 00868603000236 - Panther TPS: 2018-07-06 The purpose of Prowess Panther TPS is to provide a complete program for radiation therapy treatment planning. This includes comp