DEVICE: Sectra Workstation IDS7 (07350092810012)
Device Identifier (DI) Information
Sectra Workstation IDS7
18.2
In Commercial Distribution
Sectra AB
18.2
In Commercial Distribution
Sectra AB
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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40943 | 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
[?]Product Code | Product Code Name |
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LLZ | System, Image Processing, Radiological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K081469 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c8c7190a-91bc-4e22-9756-04bbcfcdf33d
July 06, 2018
3
October 21, 2016
July 06, 2018
3
October 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4613235200
regulatoryaffairs@sectra.com
regulatoryaffairs@sectra.com