FDA.reportPublic FDA data

Avanza

Primary DI
07540146000050
Brand
Avanza
Company
Best Theratronics Ltd
Model
Avanza
Device description
Patient positioning table
Published
2016-10-14
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
JAICouch, Radiation Therapy, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAICouch, Radiation Therapy, PoweredRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060870000AVANZAMds Nordion2006-05-15JAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540146000050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540146000050075401460000507540146000050

GMDN Terms#

Term, Definition table
TermDefinition
Teletherapy radionuclide system table, poweredA device that is a component of a teletherapy radionuclide system (commonly known as a cobalt therapy machine) and that is a powered/programmable table specifically designed to position and support a patient during treatments administered using a therapeutic radionuclide teletherapy system (e.g., a Cobalt-60 teletherapy system). It has electronic and/or software controls for table top height and positioning. It can be a stationary or mobile unit, or incorporated as an integral component of a radionuclide teletherapy system or gantry configuration.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6135912100compliance@theratronics.ca

Regulatory Flags#

DUNS number
243606832
Device count
1
Serial number
true
Manufacturing date on label
true

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
07540146000067GammaBeam1002016-10-14
07540146000074GammaBeam5002016-10-14
00754014600106RaycellMK12019-07-16
00754014600014Gammacell10002016-09-24
00754014600021Gammacell30002016-09-24
00754014600038TheratronEquinox2016-10-14
00754014600052AvanzaAvanza2016-10-14
00754014600069GammaBeam1002016-10-14
00754014600076GammaBeam5002016-10-14
00754014600045RaycellMk22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120425Opti Handle Thermoplastic AdapterQfixJAI2026-05-18
00841962120456Alta for HexaPODQfixJAI2026-01-14
00841439115152Upright Arm Positioner MEDTEC, INC.JAI2026-01-08
00841962120388Lumen AirShuttleQfixJAI2025-12-02
00841962120395Symphony Locating Bar, PH StyleQfixJAI2025-12-02
00841962120401Portrait Head Only Mask Adapter for Access SupineQfixJAI2025-12-02
00841962120418Portrait Head & Neck Mask Adapter for Access SupineQfixJAI2025-12-02
10841962119457Symphony Locating Bar, Prodigy2™QfixJAI2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAI2025-10-23
00841439114841ZiFix TraverseMEDTEC, INC.JAI2025-09-12
00841962120340Edge Guide SystemQfixJAI2025-09-11
00841962119481Symphony™QfixJAI2025-07-09
00841962119498AirDrive Trolley™QfixJAI2025-07-09
00841962119504Access Arm SupportQfixJAI2025-07-09
00841962119511Access Wrist SupportQfixJAI2025-07-09
00841962119528AirShuttle Locating BarQfixJAI2025-07-09
00841962119535AirShuttle Locating BarQfixJAI2025-07-09
00841962119542AirShuttle Transfer HandleQfixJAI2025-07-09
00841962119559InfinityLock™QfixJAI2025-07-09
00841962119573AirShuttle Transfer HandleQfixJAI2025-07-09
00841962119580InfinityLock™QfixJAI2025-07-09
00841962119597AltaQfixJAI2025-07-09
00841962119603AltaQfixJAI2025-07-09
00841962119610Locating BarQfixJAI2025-07-09
00841962119627FlexLock™QfixJAI2025-07-09
00841962119689Stradivarius™QfixJAI2025-07-09
00841962119696Encompass™QfixJAI2025-07-09
00841962119702Encompass™QfixJAI2025-07-09
00841962119719Encompass™QfixJAI2025-07-09
00841962119726AltaQfixJAI2025-07-09