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FDA 510(k)

ACCESS BREAST COIL

K-Number: K052045 · 2005-08-24

ApplicantConfirma, Inc.
Decision Date2005-08-24
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCESS BREAST COIL is the device name listed in this FDA 510(k) record. The listed applicant is Confirma, Inc.. It received FDA 510(k) clearance on 2005-08-24 under 510(k) number K052045. 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 ACCESS BREAST COIL?

ACCESS BREAST COIL is a medical device that received FDA 510(k) clearance on 2005-08-24. The listed applicant is Confirma, Inc.. The 510(k) number is K052045.

When did ACCESS BREAST COIL receive FDA 510(k) clearance?

ACCESS BREAST COIL received FDA 510(k) clearance on 2005-08-24, under 510(k) number K052045.

Who is the listed applicant for ACCESS BREAST COIL?

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

What is the FDA product code for ACCESS BREAST COIL?

The FDA product code for ACCESS BREAST COIL is MOS.

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Other records listing Confirma, 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.

K092954CADSTREAM VERSION 5K081556CADSTREAM, VERSION 5.0K071534CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTSK060547ACCESS BREAST COIL 4/SMSK043216CADSTREAM VERSION 4.0K041020CADSTREAM VERSION 3.1

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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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