DeepCT— 510(k) K182875

Substantially Equivalent

Deep01 Limited

FDA 510(k) clearance K182875 for DeepCT, Substantially Equivalent on 2019-07-10. Applicant: Deep01 Limited. Device class: 2.

Clearance details

Applicant
Deep01 Limited
Product code
Code QAS
Device class
Class 2
Regulation
21 CFR 892.2080
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taipei City, TW
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