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510(k) K202238

SIGNA Artist by Ge Healthcare (Tianjin) Company Limited — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2020
Date Received
August 7, 2020
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

Other clearances by Ge Healthcare (Tianjin) Company Limited

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  • K211980 — SIGNA Prime (January 16, 2022)
  • K192426 — Signa Voyager, Signa Voyager Quantum (October 1, 2019)

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