MR Contour DL— 510(k) K242925

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K242925 for MR Contour DL, Substantially Equivalent on 2025-04-01. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant
GE Healthcare
Product code
Code QKB
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chicago, IL, US
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