Panther OIS

Basic Information

• Brand Name: Panther OIS
• Primary DI: 00859032007224
• Version / Model: 3.1
• Company Name: Prowess, Inc.
• Labeler DUNS: 002162728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-19
• Public Version: 1
• Public Version Date: 2024-12-27
• Public Version Status: New
• Public Device Record Key: 9d2bb47e-ecf8-4dec-ac6a-9d36adf0ad32

Device Description

Panther OIS 3.1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36056	Radiation therapy treatment record/verify system	A dedicated information system comprising computers and software intended to reduce human error by monitoring linear accelerator parameters to verify that the proper radiotherapy treatment is being delivered, and to provide a permanent record. It permits a computer verification of all treatment parameters prior to the commencement of a patient's treatment. Patient information, treatment machine parameters and the dose prescription relating to that patient's treatment are entered into a patient file and stored. Comparisons are made by the record and verify system and system interlocks to ensure that treatment is not permitted if any parameters are outside the predetermined tolerances.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859032007224	GS1

Premarket Submissions

Submission Number	Supplement Number
K211760	000