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FDA 510(k)

16 Breast Coil

K-Number: K233348 · 2023-10-24

ApplicantPhilips Medical System Nederlands B.V.
Decision Date2023-10-24
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

16 Breast Coil is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical System Nederlands B.V.. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K233348. 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 16 Breast Coil?

16 Breast Coil is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Philips Medical System Nederlands B.V.. The 510(k) number is K233348.

When did 16 Breast Coil receive FDA 510(k) clearance?

16 Breast Coil received FDA 510(k) clearance on 2023-10-24, under 510(k) number K233348.

Who is the listed applicant for 16 Breast Coil?

The FDA 510(k) record lists Philips Medical System Nederlands B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 16 Breast Coil?

The FDA product code for 16 Breast Coil is MOS.

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

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

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