DeepCT

Radiological Computer-assisted Triage And Notification Software

Deep01 Limited

The following data is part of a premarket notification filed by Deep01 Limited with the FDA for Deepct.

Pre-market Notification Details

Device IDK182875
510k NumberK182875
Device Name:DeepCT
ClassificationRadiological Computer-assisted Triage And Notification Software
Applicant Deep01 Limited Rm. 5, 11F., No.162, Sec. 4, Roosevelt Rd. Taipei City,  TW 10091
ContactWilliam Lai
CorrespondentWilliam Lai
Deep01 Limited Rm. 5, 11F., No.162, Sec. 4, Roosevelt Rd. Taipei City,  TW 10091
Product CodeQAS  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-12
Decision Date2019-07-10

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