Duns Number:693942471
Device Description: Ziostation2 is a basic DICOM image management system to further aid clinicians in their an Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging toolsand techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound,Digital X-ray X-ray Angiography, PET, SPECT, NM, SC, Mammography, X-ray Radiofluoroscopic image, RTImage.
Catalog Number
-
Brand Name
Ziostation2
Version/Model Number
Ziostation2
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)
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FDA Premarket Submission
K151212
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
eece1bf9-b107-4db4-93b6-979f668d2af4
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
June 30, 2017
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. | 1 |