DEVICE: Sectra Workstation IDS7 (07350092810012)

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Device Identifier (DI) Information

Sectra Workstation IDS7
18.2

Sectra AB
07350092810012
GS1
1
Sectra Workstation is intended for the display and manipulation of medical images and other related medical information. It can show images from different sources and interface with various image storage and printing devices using DICOM and similar interface standards. Areas of application include, e.g., radiology, mammography, pathology, orthopedic preoperative planning and postoperative follow-up. Lossy compressed mammographic images are not intended for diagnostic review. For primary diagnosis, post-process DICOM “for presentation” images should be used. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Radiology picture archiving and communication system workstation A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.
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FDA Product Code

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Product Code Product Code Name
LLZ System, Image Processing, Radiological
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 21, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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No
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No CLOSE

Customer Contact

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+4613235200
regulatoryaffairs@sectra.com
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