FDA 510(k)

CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16

K-Number: K061952 · 2006-07-28

ApplicantInvivo

Decision Date2006-07-28

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 is the device name listed in this FDA 510(k) record. The listed applicant is Invivo. It received FDA 510(k) clearance on 2006-07-28 under 510(k) number K061952. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16?

CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 is a medical device that received FDA 510(k) clearance on 2006-07-28. The listed applicant is Invivo. The 510(k) number is K061952.

When did CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 receive FDA 510(k) clearance?

CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 received FDA 510(k) clearance on 2006-07-28, under 510(k) number K061952.

Who is the listed applicant for CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16?

The FDA 510(k) record lists Invivo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16?

The FDA product code for CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 is MOS.

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Other records listing Invivo as applicant

K0919021.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 K082987HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL K082916HRB-127-32 HIGH RESOLUTION BRAIN COIL K072873LBS-63-16 BREAST ARRAY COIL K072874LBS-127-16 BREAST ARRAY COIL

Related Devices (Code: MOS)

K262330dS 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 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLC K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.