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FDA 510(k)

3.0T Air MP M, 3.0T Air MP L

K-Number: K182504 · 2018-10-12

ApplicantGe Healthcare Coils (Usa Instruments, Inc.)
Decision Date2018-10-12
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3.0T Air MP M, 3.0T Air MP L is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K182504. 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 3.0T Air MP M, 3.0T Air MP L?

3.0T Air MP M, 3.0T Air MP L is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K182504.

When did 3.0T Air MP M, 3.0T Air MP L receive FDA 510(k) clearance?

3.0T Air MP M, 3.0T Air MP L received FDA 510(k) clearance on 2018-10-12, under 510(k) number K182504.

Who is the listed applicant for 3.0T Air MP M, 3.0T Air MP L?

The FDA 510(k) record lists Ge Healthcare Coils (Usa Instruments, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3.0T Air MP M, 3.0T Air MP L?

The FDA product code for 3.0T Air MP M, 3.0T Air MP L is MOS.

Other records listing Ge Healthcare Coils (Usa Instruments, Inc.) 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.

K2537383.0T AIR 32CH HNAK2233783.0T 16ch AIR AAK18066648CH Head CoilK172695AIR Anterior Array, AIR Posterior ArrayK16320548CH Head Coil

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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