Sectra Workstation

GUDID 07350092810418

Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and ophthalmology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants. Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review. Only for the United States: - Mammographic images must be reviewed on a monitor approved by FDA for this purpose. Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used. Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast.

Sectra AB

Radiology picture archiving and communication system workstation
Primary Device ID07350092810418
NIH Device Record Key0b3d9465-d6bd-45ff-923b-00394f491fde
Commercial Distribution StatusIn Commercial Distribution
Brand NameSectra Workstation
Version Model Number24.2
Company DUNS354117848
Company NameSectra AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com
Phone+4613235200
Emailregulatoryaffairs@sectra.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107350092810418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-24
Device Publish Date2022-10-16

On-Brand Devices [Sectra Workstation]

07350092810159Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810098Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810074Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810067Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810050Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810036Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810234Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810210Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810265Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810326Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810357Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810371Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810418Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810449Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810470Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810517Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
07350092810531Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
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