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510(k) K123417

BRIVO MR355, OPTIMA MR360 by Ge Hangwei Medical Systems Co., Ltd. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2013
Date Received
November 6, 2012
Clearance Type
Traditional
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 Hangwei Medical Systems Co., Ltd.

  • K233749 — Revolution Ascend Sliding (February 22, 2024)
  • K192956 — Auto Positioning (January 16, 2020)
  • K192686 — Revolution Maxima, Revolution Ace (October 24, 2019)
  • K171013 — Revolution ACT (June 5, 2017)
  • K160131 — OEC Elite MiniView (June 21, 2016)
  • K123596 — OPTIMA CT520 (February 8, 2013)
  • K122694 — GE 8CH FOOT ANKLE COIL (October 25, 2012)
  • K120778 — BRIVO MR355 (March 27, 2012)
  • K103330 — BRIVO MR355, OPTIMA MR360 (February 11, 2011)

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  • K252379 — AIR Recon DL (December 23, 2025)
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