Imbio PHA (4.0.0)— 510(k) K241847

Substantially Equivalent

Imbio, Inc.

FDA 510(k) clearance K241847 for Imbio PHA (4.0.0), Substantially Equivalent on 2024-08-30. Applicant: Imbio, Inc.. Device class: 2.

Clearance details

Applicant: Imbio, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-06-26
Decision date: 2024-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Imbio, Inc.

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