510(k) Report

Devices descending from K030737

10 later devices reach Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251881HippoMind (v1.0)Hippoclinic20250—
+1K041264Elekta OYElekta Neuromag OY20048—
+2K210199Ricoh MegRicoh Company, Ltd.20210—
+2K191785Orion LifeSpan MEGCompumedics Limited20200—
+2K091393Elekta Neuromag with MaxfilterElekta Neuromag OY20102—
+2K081430Elekta Neuromag with Maxwell Filter with Internal Active ShieldingElekta Neuromag OY20080—
+2K070358MaxinsightEemagine Medical Imaging Solutions GmbH20070—
+2K050035Elekta Neuromag with Maxwell FilterElekta Neuromag OY20054—
+3K233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY20241—
+4K260563CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND Neuro20260—