Saige-Q

Radiological Computer-assisted Prioritization Software For Lesions

DeepHealth, Inc.

The following data is part of a premarket notification filed by Deephealth, Inc. with the FDA for Saige-q.

Pre-market Notification Details

Device IDK203517
510k NumberK203517
Device Name:Saige-Q
ClassificationRadiological Computer-assisted Prioritization Software For Lesions
Applicant DeepHealth, Inc. 1000 Massachusetts Ave Cambridge,  MA  02138
ContactA. Gregory Sorensen
CorrespondentA Gregory Sorensen
DeepHealth, Inc. 1000 Massachusetts Ave Cambridge,  MA  02138
Product CodeQFM  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-30
Decision Date2021-04-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860005144006 K203517 000

Trademark Results [Saige-Q]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAIGE-Q
SAIGE-Q
90258964 not registered Live/Pending
Deephealth
2020-10-16

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