Panther OIS

GUDID 00859032007156

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 Radiation therapy treatment record/verify system
Primary Device ID00859032007156
NIH Device Record Key0c229143-4286-4d44-9d4c-c5a7c2ab2158
Commercial Distribution Discontinuation2027-03-16
Commercial Distribution StatusIn Commercial Distribution
Brand NamePanther OIS
Version Model Numberv3.0
Company DUNS002162728
Company NamePROWESS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859032007156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-24
Device Publish Date2022-03-16

Devices Manufactured by PROWESS, INC.

00859032007156 - Panther OIS2022-03-24
00859032007156 - Panther OIS2022-03-24
00859032007064 - Panther TPS2021-11-09
00859032007088 - Panther TPS2021-11-09
00859032007095 - Panther OIS|R&V2021-11-09
00859032007132 - Panther TPS2021-11-09
00859032007002 - Panther Brachy2018-07-12
00868603000236 - Panther TPS2018-07-06 The purpose of Prowess Panther TPS is to provide a complete program for radiation therapy treatment planning. This includes comp

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