Panther OIS|R&V

GUDID 00859032007095

PROWESS, INC.

Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system Radiation therapy treatment record/verify system

• Primary Device ID: 00859032007095
• NIH Device Record Key: ef701fb4-fe93-4685-a42e-f43792559a15
• Commercial Distribution Discontinuation: 2025-05-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panther OIS|R&V
• Version Model Number: v2.31
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859032007095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100801

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2021-11-09
• Device Publish Date: 2021-11-01

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
• 00859032007095 - Panther OIS|R&V: 2021-11-09
• 00859032007132 - Panther TPS: 2021-11-09
• 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