FDA.reportPublic FDA data

GammaBeam

Primary DI
00754014600069
Brand
GammaBeam
Company
Best Theratronics Ltd
Model
100
Device description
A Cobalt Teletherapydevice by which gamma radiation is delivered for the treatment of cancer
Published
2016-10-14
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
IWBSystem, Radiation Therapy, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWBSystem, Radiation Therapy, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142219000GammaBeam 100Best Theratronics Limited2014-11-13IWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00754014600069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754014600069007540146000697540146000690754014600069

GMDN Terms#

Term, Definition table
TermDefinition
Teletherapy radionuclide system, conventionalA stationary assembly of computer-based devices designed to deliver a therapeutic radiation dose to an anatomical region from a single external radiation beam produced by a radionuclide source, typically to treat malignant tumours; it does not provide image-guided radiation therapy (IGRT) functionality during treatment delivery. A typical system is: 1) the treatment head (a shielded source vault containing a single radioactive source); 2) a rotating or fixed gantry with the treatment head; 3) a collimator mechanism attached to the gantry to align the treatment beam; 4) a moveable patient table; and 5) an operator's console with controls. It is commonly known as a cobalt therapy machine.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6135912100compliance@theratronics.ca

Regulatory Flags#

DUNS number
243606832
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
07540146000012Gammacell10002016-09-24
07540146000029Gammacell30002016-09-24
07540146000043RaycellMk22016-09-24
07540146000104RaycellMK12019-07-16
07540146000036TheratronEquinox2016-10-14
07540146000050AvanzaAvanza2016-10-14
07540146000067GammaBeam1002016-10-14
07540146000074GammaBeam5002016-10-14
00754014600106RaycellMK12019-07-16
00754014600014Gammacell10002016-09-24
00754014600021Gammacell30002016-09-24
00754014600038TheratronEquinox2016-10-14
00754014600052AvanzaAvanza2016-10-14
00754014600076GammaBeam5002016-10-14
00754014600045RaycellMk22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014221910Galaxy RTiAkesis Inc.IWB2026-05-11
06973682570151CybeRayOur United CorporationIWB2026-04-24
07340201503898Leksell GammaPlanElekta Solutions ABIWB2026-02-04
06974783050023SMD-XGD/AR GalaxyOur Smd Medical (Wuhan) Co., Ltd.IWB2025-05-30
06974783050009SMD Galaxy RTxOur Smd Medical (Wuhan) Co., Ltd.IWB2025-05-26
07340201502136Leksell GammaPlanElekta Solutions ABIWB2024-02-14
07340201501139Leksell Gamma Knife EspritElekta Solutions ABIWB2023-03-27
07340048311786Leksell Gamma Knife IconElekta Instrument ABIWB2021-03-28
07340048311700Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311731Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311755Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311762Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311779Leksell Gamma Knife IconElekta Instrument ABIWB2021-03-28
07540180000238Clarity®Elekta Solutions ABIWB2020-06-19
07340048311878Leksell GammaPlanElekta Instrument ABIWB2020-06-13
07540180000221Clarity®Elekta Solutions ABIWB2020-05-22
05060608880522ISORAD Detector, 1-4MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880539ISORAD Detector, 1-4MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880546ISORAD Detector, 6-12MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880553ISORAD Detector, 6-12MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880560ISORAD Detector, 6-12MV (-) 1.5mSUN NUCLEAR CORP.IWB2019-05-21
05060608880577ISORAD Detector, 15-25MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880584ISORAD Detector, 15-25MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880591ISORAD Detector, 15-25MV (-) 1.5mSUN NUCLEAR CORP.IWB2019-05-21
07340048306447Leksell Gamma Knife Perfexion/IconElekta Instrument ABIWB2019-04-17
07540180000214Clarity®Elekta Solutions ABIWB2019-03-27
10850002615361GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615378GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615385GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615392GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22