FDA.reportPublic FDA data

Portable

Primary DI
07540146000098
Brand
Portable
Company
Best Medical Canada Ltd
Model
Dosimeter
Device description
MOSFET radiation therapy dosimetry system
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K092285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092285000PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90Best Medical Canada , Ltd.2009-08-28IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540146000098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540146000098075401460000987540146000098

GMDN Terms#

Term, Definition table
TermDefinition
MOSFET radiation therapy dosimetry systemAn assembly of devices using metal oxide semiconductor field-effect transistor (MOSFET) technology intended to be used for on-the-spot patient or anthropomorphic radiation dose verification and monitoring during radiation therapy and radiology procedures. It typically consists of several wire-connected MOSFET dosimeters, a portable battery-powered dosimeter reader, and application software; it may include wireless data exchanging technology. Applications typically include radiation oncology therapy and dosimetry, treatment plan verification for in vivo dosimetry, brachytherapy, intraoperative radiation therapy, image-guided radiation therapy, and research.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6135912100compliance@theratronics.ca

Regulatory Flags#

DUNS number
247902336
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540146000081mobileMOSFETDosimeter2016-09-30
00754014600083mobileMOSFETDosimeter2016-09-30
00754014600090PortableDosimeter2016-09-30

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