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FDA 510(k)

CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM

K-Number: K973630 · 1997-12-05

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1997-12-05
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1997-12-05 under 510(k) number K973630. 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 CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM?

CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-05. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K973630.

When did CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM receive FDA 510(k) clearance?

CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM received FDA 510(k) clearance on 1997-12-05, under 510(k) number K973630.

Who is the listed applicant for CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM?

The FDA product code for CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM is MOS.

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Related Devices (Code: MOS)

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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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