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510(k) K082485

MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A by Neusoft Medical Systems Co., Ltd. — Product Code LNH

K082485 is an FDA 510(k) premarket notification submitted by Neusoft Medical Systems Co., Ltd. for the device "MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A". The FDA issued a decision of Substantially Equivalent on September 9, 2008. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Neusoft Medical Systems Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2008
Date Received
August 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Neusoft Medical Systems Co., Ltd.

  • K230220 — NeuViz 128 Multi-Slice CT Scanner System (October 11, 2023)
  • K171198 — NeuViz 16 Essence Multi-slice CT Scanner System (December 7, 2017)
  • K171201 — NeuViz Prime Multi-slice CT Scanner System (September 13, 2017)
  • K151383 — NeuViz 128 Multi-slice CT Scanner System (November 4, 2015)
  • K151403 — Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron (November 2, 2015)
  • K133373 — CLEARVIEW (December 3, 2014)
  • K121792 — NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM (November 16, 2012)
  • K110077 — NEUCOLONCARE (January 28, 2011)
  • K102435 — BEYONDIMAGE WORKSTATION (October 15, 2010)
  • K092742 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (September 22, 2009)

Other clearances for product code LNH

  • K253808 — AIR Recon DL (August 13, 2026)
  • K260852 — MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure (July 31, 2026)
  • K261331 — I-Genius (100019400) (July 31, 2026)
  • K260113 — uMR Astra (May 22, 2026)
  • K253862 — APERTO Lucent MRI System (April 6, 2026)
  • K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing (March 27, 2026)
  • K260746 — S-scan Open (100001800) (March 27, 2026)
  • K251937 — nordicAudio (1.0) (March 20, 2026)
  • K254277 — Embrace Neonatal MRI System (March 13, 2026)
  • K253413 — LiverMultiScan (v6.0) (March 9, 2026)

FDA data resources