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FDA 510(k)

1.5T GEM RT OPEN ARRAY

K-Number: K123327 · 2013-01-11

ApplicantGe Healthcare Coils (Usa Instruments, Inc.)
Decision Date2013-01-11
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T GEM RT OPEN ARRAY 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 2013-01-11 under 510(k) number K123327. 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 1.5T GEM RT OPEN ARRAY?

1.5T GEM RT OPEN ARRAY is a medical device that received FDA 510(k) clearance on 2013-01-11. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K123327.

When did 1.5T GEM RT OPEN ARRAY receive FDA 510(k) clearance?

1.5T GEM RT OPEN ARRAY received FDA 510(k) clearance on 2013-01-11, under 510(k) number K123327.

Who is the listed applicant for 1.5T GEM RT OPEN ARRAY?

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 1.5T GEM RT OPEN ARRAY?

The FDA product code for 1.5T GEM RT OPEN ARRAY is MOS.

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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 AAK1825043.0T Air MP M, 3.0T Air MP LK18066648CH Head CoilK172695AIR Anterior Array, AIR Posterior ArrayK16320548CH Head Coil

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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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