CONTINUUM PACS

System, Image Management, Ophthalmic

Integrated Ophthalmic Systems, Inc.

The following data is part of a premarket notification filed by Integrated Ophthalmic Systems, Inc. with the FDA for Continuum Pacs.

Pre-market Notification Details

Device IDK200385
510k NumberK200385
Device Name:CONTINUUM PACS
ClassificationSystem, Image Management, Ophthalmic
Applicant Integrated Ophthalmic Systems, Inc. 596 Main Street Woburn,  MA  01801
ContactMatthew Carnevale
CorrespondentAnna Reifschneider
Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum,  FL  33155 -3708
Product CodeNFJ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelOphthalmic
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-02-18
Decision Date2020-03-16

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.