Myomics— 510(k) K241922

Substantially Equivalent

Phantomics, Inc.

FDA 510(k) clearance K241922 for Myomics, Substantially Equivalent on 2025-02-28. Applicant: Phantomics, Inc.. Device class: 2.

Clearance details

Applicant: Phantomics, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-07-01
Decision date: 2025-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Phantomics, Inc.

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