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FDA 510(k)

1.5T HD T/R Knee Array (10-F34127)

K-Number: K231085 · 2023-08-18

ApplicantShenzhen RF Tech Co., Ltd.
Decision Date2023-08-18
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T HD T/R Knee Array (10-F34127) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen RF Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231085. 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 HD T/R Knee Array (10-F34127)?

1.5T HD T/R Knee Array (10-F34127) is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Shenzhen RF Tech Co., Ltd.. The 510(k) number is K231085.

When did 1.5T HD T/R Knee Array (10-F34127) receive FDA 510(k) clearance?

1.5T HD T/R Knee Array (10-F34127) received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231085.

Who is the listed applicant for 1.5T HD T/R Knee Array (10-F34127)?

The FDA 510(k) record lists Shenzhen RF Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1.5T HD T/R Knee Array (10-F34127)?

The FDA product code for 1.5T HD T/R Knee Array (10-F34127) is MOS.

Other records listing Shenzhen RF Tech Co., Ltd. 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.

K252587HD 8Ch Wrist ArrayK252876GEM 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 OnlyK252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive OnlyK2232031.5T 24E Posterior ArrayK2232258ch T/R Knee CoilK2232398ch Wrist 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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