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510(k) K192426

Signa Voyager, Signa Voyager Quantum by Ge Healthcare (Tianjin) Company Limited — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2019
Date Received
September 5, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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