FullFocus

Digital Pathology Image Viewing And Management Software

Paige.AI, Inc

The following data is part of a premarket notification filed by Paige.ai, Inc with the FDA for Fullfocus.

Pre-market Notification Details

Device IDK201005
510k NumberK201005
Device Name:FullFocus
ClassificationDigital Pathology Image Viewing And Management Software
Applicant Paige.AI, Inc 11 Times Square, 37th Floor New York,  NY  10036
ContactJillian Sue
CorrespondentJillian Sue
Paige.AI, Inc 11 Times Square, 37th Floor New York,  NY  10036
Product CodeQKQ  
CFR Regulation Number864.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-16
Decision Date2020-07-15

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