SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL— 510(k) K003946

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K003946 for SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL, Substantially Equivalent on 2001-02-27. Applicant: GE Medical Systems. Device class: 2.

Clearance details

Applicant
GE Medical Systems
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
Milwaukee, WI, US
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