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FDA 510(k)

MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX

K-Number: K013985 · 2002-02-01

ApplicantMachnet BV
Decision Date2002-02-01
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX is the device name listed in this FDA 510(k) record. The listed applicant is Machnet BV. It received FDA 510(k) clearance on 2002-02-01 under 510(k) number K013985. 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 MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX?

MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX is a medical device that received FDA 510(k) clearance on 2002-02-01. The listed applicant is Machnet BV. The 510(k) number is K013985.

When did MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX receive FDA 510(k) clearance?

MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX received FDA 510(k) clearance on 2002-02-01, under 510(k) number K013985.

Who is the listed applicant for MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX?

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

What is the FDA product code for MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX?

The FDA product code for MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX is MOS.

Related Clinical Trials

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.

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Other records listing Machnet BV 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.

K020289MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIASK012491MACHNET CAROTIDS COIL ARRAY ASSEMBLY

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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