TBI Detector 110V

Primary DI
08717953004031
Brand
TBI Detector 110V
Company
Cablon Medical B.V.
Model
C01-05-02
Catalog number
C01-05-02
Device description
The TBI Detector is used in radiation therapy clinics to acquire MV images by means of an imaging device, in order to be forwarded to the Theraview imaging software.
Published
2024-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

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
K960510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960510000THERAVIEWInfimed, Inc.1996-04-22IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717953004031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717953004031087179530040318717953004031

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy digital imagerAn automated device that is typically mounted on the gantry of a linear accelerator and intended to produce digital images of x-rayed anatomical landmarks to guide radiation treatment (e.g., tracking/targeting tumours). The device may be a digital imaging panel (e.g., of silicon) on robotic arms; it may also have an x-ray source to generate higher quality images.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius80 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
415163591
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717953004000TheraviewC01-01-00C01-01-002024-11-11
08717953004048PIM Fixed Hand Palm ScannerC01-09-02C01-09-022024-11-11
08717953004055PIM Portable Hand Palm ScannerC01-09-03C01-09-032024-11-11

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