Synergy ODM

GUDID 00850003069081

Synergy ODM 4.09.500 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.

TOPCON HEALTHCARE SOLUTIONS, INC.

Camera application software
Primary Device ID00850003069081
NIH Device Record Key4abf0480-1488-44f3-8ec2-35cd8ba001c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynergy ODM
Version Model Number4.09.500
Company DUNS081155097
Company NameTOPCON HEALTHCARE SOLUTIONS, 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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003069081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFJSystem, Image Management, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-10
Device Publish Date2020-03-02

On-Brand Devices [Synergy ODM]

00850003069081Synergy ODM 4.09.500 is a comprehensive software platform intended for use in importing, process
00850003069036Synergy ODM 4.10.500 is a comprehensive software platform intended for use in importing, process

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