Duns Number:713565195
Device Description: The product “Synapse 3D Base Tools” is a system that receives and retrieves DICOM data fro The product “Synapse 3D Base Tools” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis.
Catalog Number
-
Brand Name
Synapse 3D
Version/Model Number
Synapse 3D
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)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LLZ
Product Code Name
System, image processing, radiological
Public Device Record Key
d45bac45-e6f2-4a18-b090-f5cfd358bf78
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |