1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA— 510(k) K182590

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K182590 for 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA, Substantially Equivalent on 2018-10-19. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant
GE Healthcare
Product code
Code MOS
Device class
Class 2
Regulation
21 CFR 892.1000
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waukesha, WI, US
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