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510(k) K120701

M2 WRIST MRI SYSTEM by Aspect Imaging, Ltd. — Product Code LNH

K120701 is an FDA 510(k) premarket notification submitted by Aspect Imaging, Ltd. for the device "M2 WRIST MRI SYSTEM". The FDA issued a decision of Substantially Equivalent on February 7, 2013. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Aspect Imaging, Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2013
Date Received
March 7, 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 Aspect Imaging, Ltd.

  • K254277 — Embrace Neonatal MRI System (March 13, 2026)
  • K170978 — Embrace Neonatal MRI System (July 19, 2017)
  • K160185 — Wrist 3 (March 1, 2016)
  • K130692 — M2 WRIST 2 MRI SYSTEM (January 14, 2014)

Other clearances for product code LNH

  • 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)
  • K251901 — Magnifico Open (100009900) (March 5, 2026)
  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)

FDA data resources