ActivSight Intraoperative Imaging System

Confocal Optical Imaging

Activ Surgical, Inc.

The following data is part of a premarket notification filed by Activ Surgical, Inc. with the FDA for Activsight Intraoperative Imaging System.

Pre-market Notification Details

Device IDK203550
510k NumberK203550
Device Name:ActivSight Intraoperative Imaging System
ClassificationConfocal Optical Imaging
Applicant Activ Surgical, Inc. 840 Summer Street Boston,  MA  02127
ContactMatthew King
CorrespondentMatthew King
Activ Surgical, Inc. 840 Summer Street Boston,  MA  02127
Product CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-04
Decision Date2021-04-08

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