Duns Number:354117848
Device Description: Sectra Workstation is intended for the display and manipulation of medical images and othe 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.
Catalog Number
-
Brand Name
Sectra Workstation IDS7
Version/Model Number
18.2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K081469
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
c8c7190a-91bc-4e22-9756-04bbcfcdf33d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |