DeepXray— 510(k) K223621

Substantially Equivalent

Alpha Intelligence Manifolds, Inc.

FDA 510(k) clearance K223621 for DeepXray, Substantially Equivalent on 2023-09-08. Applicant: Alpha Intelligence Manifolds, Inc.. Device class: 2.

Clearance details

Applicant: Alpha Intelligence Manifolds, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2022-12-05
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.