FDA.reportPublic FDA data

Portable

Primary DI
00754014600090
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 n
Rx
true
OTC
false
Sterile
false
Single use
false

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
00754014600090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754014600090007540146000907540146000900754014600090

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540146000081mobileMOSFETDosimeter2016-09-30
07540146000098PortableDosimeter2016-09-30
00754014600083mobileMOSFETDosimeter2016-09-30

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