Sectra Calibration Unit

GUDID 07350092810395

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.

Sectra AB

General-purpose diagnostic x-ray phantom, test object
Primary Device ID07350092810395
NIH Device Record Key280e427c-bbba-44bf-9567-c663f49090af
Commercial Distribution StatusIn Commercial Distribution
Brand NameSectra Calibration Unit
Version Model Number2
Company DUNS354117848
Company NameSectra AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4613235206
Emailregulatoryaffairs@sectra.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107350092810395 [Primary]

FDA Product Code

LHOInstrument, Quality-Assurance, Radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-15
Device Publish Date2022-11-07

Devices Manufactured by Sectra AB

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07350092810494 - Sectra Orthopedic Package2024-01-10 Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measure
07350092810487 - Sectra Digital Pathology Module2023-11-21 For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital
07350092810470 - Sectra Workstation2023-11-20 Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) an
07350092810449 - Sectra Workstation2023-06-29 Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) an
07350092810456 - Sectra Digital Pathology Module2023-06-29 For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital
07350092810463 - Sectra Orthopedic Package2023-06-29 Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measure
07350092810395 - Sectra Calibration Unit2022-11-15The 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.
07350092810395 - Sectra Calibration Unit2022-11-15 The Sectra Calibration Unit consists of calibration holders and markers. The calibration holders are intended to correctly place
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