510(k) Report

Devices descending from K071099

8 later devices reach Neuro II-SE, Models: or-DR-or, or-MB through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133692Imri 1.5T and Imri 3T SImris, Inc.20143Class I
+1K110411Atama SystemMonteris Medical, Inc.20111—
+1K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+1K091166IMRXImris, Inc.20091—
+2K212367IMRIS iMRI 3T VDeerfield Imaging, Inc.20212Class I
+2K132444Atama SystemMonteris Medical,20140—
+3K252239InVision™ 3T Recharge Operating SuiteImris Imaging, Inc.20250—
+3K240157InVision™ 1.5 Surgical TheatreDeerfield Imaging, Inc.20240—