Medical Device Manufacturer · US , Omaha , NE

Resonance Innovations, LLC - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2006

Recent clearances: Siemens 3.0T PROCURE Array Coil, Siemens 3.0 Blanket Array Coil, 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL

View 8 510(k) Devices ↓

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Resonance Innovations, LLC Radiology ✕

8 devices

1-8 of 8

Cleared Dec 05, 2014

Siemens 3.0T PROCURE Array Coil

Radiology · 77d

Cleared Oct 23, 2014

Siemens 3.0 Blanket Array Coil

Radiology · 28d

Cleared May 12, 2014

1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL

Radiology · 63d

Cleared Feb 26, 2014

ST SENSE NV 8 ARRAY COIL

Radiology · 22d

Cleared Jan 27, 2014

1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY

Radiology · 32d

Cleared May 20, 2013

3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL

Radiology · 87d

Cleared May 25, 2006

3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000

Radiology · 28d

Cleared Mar 31, 2006

1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL

Radiology · 16d