Continuum PACS

GUDID G20910

Ophthalmic PACS

Integrated Ophthalmic Systems, Inc.

Ophthalmology PACS software
Primary Device IDG20910
NIH Device Record Key4f0f656b-ec34-4e0f-a1cd-8b9966e417f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameContinuum PACS
Version Model Number1
Company DUNS081158697
Company NameIntegrated Ophthalmic 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
HIBCCG20910 [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 Date2024-08-27
Device Publish Date2024-08-19

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