ST SENSE NV 8 ARRAY COIL— 510(k) K140282

Clearance details

Applicant

Resonance Innovations, LLC

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2014-02-04

Decision date

2014-02-26

Decision

Substantially Equivalent

Clearance type

Special

Location

Omaha, NE, US

• K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T2026-07-30
• K262294 — dS FootAnkle 16Ch 1.5T +5 more2026-07-24
• K260947 — 0.55T 12Ch Breast Coil2026-04-23
• K252587 — HD 8Ch Wrist Array2026-04-14
• K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more2026-04-01

• K142676 — Siemens 3.0T PROCURE Array Coil2014-12-05
• K142755 — Siemens 3.0 Blanket Array Coil2014-10-23
• K140606 — 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL2014-05-12
• K133986 — 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY2014-01-27
• K130457 — 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL2013-05-20