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Sectra Calibration Unit

Primary DI
07350092810395
Brand
Sectra Calibration Unit
Company
Sectra AB
Model
2
Device description
The Sectra Calibration Unit consists of calibration holders and markers.The calibration holders are intended to correctly place the calibration markers in relation to the patient during image acquisition.The calibration markers will be visible on the x-ray images and are intended to serve as scaling references.Typical users of the device are trained professionals, for example radiology technicians.
Published
2022-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHOInstrument, Quality-Assurance, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHOInstrument, Quality-Assurance, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350092810395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350092810395073500928103957350092810395

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose diagnostic x-ray phantom, test objectA device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device used in both calibration protocols and in subjective and quantitative evaluations of various calibration and performance characteristics of conventional and digital general-purpose x-ray imaging systems. It is also used in the assessment of the performance characteristics of associated image acquisition, display, and analysis computer programs.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4613235206regulatoryaffairs@sectra.com

Regulatory Flags#

DUNS number
354117848
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350092810654Sectra Workstation 28.12026-05-12
07350092810685Sectra Digital Pathology Module5.02026-05-12
07350092810678Sectra Orthopedic Package19.22026-03-05
07350092810616Sectra Workstation 27.22025-10-27
07350092810609Sectra Orthopedic Package19.12025-07-17
07350092810593Sectra Digital Pathology Module4.22025-04-09
07350092810579Sectra Workstation 27.12025-04-08
07350092810562Sectra Orthopedic Package18.22025-01-12
07350092810524Sectra Digital Pathology Module4.12024-10-11
07350092810531Sectra Workstation 26.22024-10-11
07350092810555Sectra Orthopedic Package18.12024-08-21
07350092810517Sectra Workstation26.12024-06-04
07350092810500Sectra Digital Pathology Module4.02024-05-07
07350092810494Sectra Orthopedic Package17.22024-01-02
07350092810487Sectra Digital Pathology Module3.42023-11-13
07350092810470Sectra Workstation25.22023-11-12
07350092810449Sectra Workstation25.12023-06-21
07350092810456Sectra Digital Pathology Module3.32023-06-21
07350092810463Sectra Orthopedic Package17.12023-06-21
07350092810432Sectra Orthopedic Package16.22022-10-18

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