System, Image Processing, Radiological

DeepLook Inc.

The following data is part of a premarket notification filed by Deeplook Inc. with the FDA for Deeplook Precise.

Pre-market Notification Details

Device IDK202084
510k NumberK202084
Device Name:DeepLook PRECISE
ClassificationSystem, Image Processing, Radiological
Applicant DeepLook Inc. 1220 Burton Street Silver Spring,  MD  20910
ContactSteven Schwadron
CorrespondentCarl Alletto
OTech Inc 8317 Belew Drive Mckinney,  TX  75071
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-27
Decision Date2021-04-09

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