CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16— 510(k) K061952

Clearance details

Applicant

Invivo

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2006-07-10

Decision date

2006-07-28

Decision

Substantially Equivalent

Clearance type

Special

Location

Florida, FL, 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

• K091902 — 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 8004842009-08-21
• K082987 — HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL2008-11-06
• K082916 — HRB-127-32 HIGH RESOLUTION BRAIN COIL2008-10-15
• K072873 — LBS-63-16 BREAST ARRAY COIL2007-11-16
• K072874 — LBS-127-16 BREAST ARRAY COIL2007-11-16