DeviceClearance

Omni Legend— 510(k) K221932

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K221932 for Omni Legend, Substantially Equivalent on 2022-09-02. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant
GE Healthcare
Product code
Code KPS
Device class
Class 2
Regulation
21 CFR 892.1200
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tirat Hacarmel, IL
Download summary PDFView on FDA.gov ↗

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Recalls naming K221932

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221932.

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