Imbio RV/LV Software— 510(k) K203256

Substantially Equivalent

Imbio, LLC

FDA 510(k) clearance K203256 for Imbio RV/LV Software, Substantially Equivalent on 2021-03-09. Applicant: Imbio, LLC. Device class: 2.

Clearance details

Applicant: Imbio, LLC
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-11-04
Decision date: 2021-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Imbio, LLC

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