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FDA 510(k)

dS Breast Coil 7ch 1.5T

K-Number: K232762 · 2023-10-03

ApplicantInvivo Corporation (Business Trade Name: Philips)
Decision Date2023-10-03
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

dS Breast Coil 7ch 1.5T 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 2023-10-03 under 510(k) number K232762. 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 dS Breast Coil 7ch 1.5T?

dS Breast Coil 7ch 1.5T is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K232762.

When did dS Breast Coil 7ch 1.5T receive FDA 510(k) clearance?

dS Breast Coil 7ch 1.5T received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232762.

Who is the listed applicant for dS Breast Coil 7ch 1.5T?

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 dS Breast Coil 7ch 1.5T?

The FDA product code for dS Breast Coil 7ch 1.5T is MOS.

Other records listing Invivo Corporation (Business Trade Name: Philips) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2223258ch Wrist CoilK2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilK213735dS Sentinelle Breast 16ch 1.5T CoilK213727dS Sentinelle Breast 16ch 3.0T CoilK213351ds Head 32ch 3.0T

Related Devices (Code: MOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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, LLCK252587HD 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

View on FDA Database →

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

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