FDA.report

Odyssey

Primary DI
B211ODY520005
Brand
Odyssey
Company
PERMEDICS INC
Model
5.2.00
Device description
Odyssey is a Radiation Therapy Treatment Planning System, Windows based software system designed for treatment planning and analysis of radiation ther
Published
2017-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MUJSystem,Planning,Radiation Therapy Treatment

Product Code Classifications

CodeDeviceSpecialtyClass
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B211ODY520005PrimaryHIBCC0

GMDN Terms

TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods

Method

Contacts

PhoneEmail
(909) 478-5000support@permedics.com

Regulatory Flags

DUNS number
073238441
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B211ODY520106Odyssey5.2.012017-05-08

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07350002010839RayCareRaysearch Laboratories AB (Publ)MUJ2025-04-30
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00040695000008Radiation Planning Assistant (RPA)The University of Texas M. D. Anderson Cancer CenterMUJ2025-01-28
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00856100006370ARIA Radiation Therapy ManagementVARIAN MEDICAL SYSTEMS, INC.MUJ2024-12-20
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00859032007255Panther TPSProwess, Inc.MUJ2024-12-19
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00850800006074ViteseeVARIAN MEDICAL SYSTEMS, INC.MUJ2024-11-01
00884838122123MR-RTPhilips Medical Systems Nederland B.V.MUJ2024-06-20
00856100006349Ethos Treatment ManagementVARIAN MEDICAL SYSTEMS, INC.MUJ2024-05-10
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04065983000016SagiPlan®BEBIG Medical GmbHMUJ2023-11-28
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06973127400067MOZI TPSManteia Technologies Co.,Ltd.MUJ2023-11-06
07350002010730RayStationRaysearch Laboratories AB (Publ)MUJ2023-10-18