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FDA 510(k)

SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)

K-Number: K964969 · 1997-06-26

ApplicantGE Medical Systems
Decision Date1997-06-26
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1997-06-26 under 510(k) number K964969. 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 SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)?

SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) is a medical device that received FDA 510(k) clearance on 1997-06-26. The listed applicant is GE Medical Systems. The 510(k) number is K964969.

When did SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) receive FDA 510(k) clearance?

SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) received FDA 510(k) clearance on 1997-06-26, under 510(k) number K964969.

Who is the listed applicant for SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)?

The FDA product code for SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) is MOS.

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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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