Synthesis Vision Viewer

GUDID 75401622502219

Synthesis Health Intelligence Inc

Radiological PACS software
Primary Device ID75401622502219
NIH Device Record Key06a04888-d4b2-4a4f-9646-ed2e8552eac1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynthesis Vision Viewer
Version Model Number2.1
Company DUNS243267198
Company NameSynthesis Health Intelligence Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS175401622502219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-28
Device Publish Date2025-08-20

On-Brand Devices [Synthesis Vision Viewer]

754016225002081.0.0
754016225022022.0
754016225022192.1

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