Synergy ODM

GUDID 00852683007049

Synergy ODM 4.09 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.

TOPCON MEDICAL SYSTEMS, INC.

Camera application software
Primary Device ID00852683007049
NIH Device Record Keyf8458437-0be1-4253-b7b2-7fbd0d0c0452
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynergy ODM
Version Model Number4.09
Company DUNS053547238
Company NameTOPCON MEDICAL SYSTEMS, 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
GS100852683007049 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-12

On-Brand Devices [Synergy ODM]

00852683007049Synergy ODM 4.09 is a comprehensive software platform intended for use in importing, processing,
00852683007032Synergy ODM 4.08 is a comprehensive software platform intended for use in importing, processing,
00852683007025Synergy ODM 4.07 is a comprehensive software platform intended for use in importing, processing,
00852683007018Synergy ODM 4.06 is a comprehensive software platform intended for use in importing, processing,
00852683007001Synergy ODM 4.05 is a comprehensive software platform intended for use in importing, processing,
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.