Panther OIS

Primary DI
00859032007248
Brand
Panther OIS
Company
Prowess, Inc.
Model
3.11
Device description
Panther OIS 3.11
Published
2024-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211760000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211760000Panther OISProwess, Inc.2021-09-28IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859032007248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859032007248008590320072488590320072480859032007248

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy treatment record/verify systemA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002162728
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859032007361Panther OIS3.42026-06-09
00859032007378Panther TPS6.32026-06-09
00859032007316Panther TPS6.12026-06-01
00859032007323Panther TPS6.22026-06-01
00859032007330Panther OIS3.32026-06-01
00859032007347Panther TPS6.212026-06-01
00859032007354Panther OIS3.312026-06-01
00859032007088Panther TPSv5.612021-11-01
00859032007095Panther OIS R&Vv2.312021-11-01
00859032007033Panther OIS R&V2.22024-12-19
00859032007170Panther TPS5.72024-12-19
00859032007194Panther TPS5.72024-12-19
00859032007200Panther TPS5.82024-12-19
00859032007224Panther OIS3.12024-12-19
00859032007231Panther TPS5.812024-12-19
00859032007255Panther TPS5.92024-12-19
00859032007262Panther OIS3.122024-12-19
00859032007279Panther TPS6.02024-12-19
00859032007309Panther OIS3.22024-12-19
00859032007064Panther TPSv5.62021-11-01

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