FDA.report

InsightRT

Primary DI
B244IRT1000
Brand
InsightRT
Company
SIRIS MEDICAL, INC.
Model
IRT100
Catalog number
IRT100
Published
2016-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Premarket Submissions

SubmissionSupplement
K151560000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K151560000QuickPlanSiris Medical2015-09-11MUJ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B244IRT1000PrimaryHIBCC0

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
6503945161info@siris-medical.com

Regulatory Flags

DUNS number
079081812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
B244ISS100S0InsightRT Software Suite ServerISS100SISS100S2016-08-08

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07350002010839RayCareRaysearch Laboratories AB (Publ)MUJ2025-04-30
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06973127400067MOZI TPSManteia Technologies Co.,Ltd.MUJ2023-11-06
07350002010730RayStationRaysearch Laboratories AB (Publ)MUJ2023-10-18