FDA 510(k)

1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil

Numéro K : K222257 · 2022-08-23

DemandeurInvivo Corporation (Business Trade Name: Philips)

Date de décision2022-08-23

Code produitMOS

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation (Business Trade Name: Philips). It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K222257. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil?

1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K222257.

When did 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil receive FDA 510(k) clearance?

1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil received FDA 510(k) clearance on 2022-08-23, under 510(k) number K222257.

Who is the listed applicant for 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil?

The FDA 510(k) record lists Invivo Corporation (Business Trade Name: Philips) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil?

The FDA product code for 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil is MOS.

Essais cliniques associés

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Autres dossiers indiquant Invivo Corporation (Business Trade Name: Philips) en tant que demandeur

K232762dS Breast Coil 7ch 1.5T K2223258ch Wrist Coil K213735dS Sentinelle Breast 16ch 1.5T Coil K213727dS Sentinelle Breast 16ch 3.0T Coil K213351ds Head 32ch 3.0T

Dispositifs connexes (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 Bobine de PoitrineNeocoil, 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.

Source officielle

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