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FDA 510(k)

LBS-127-16 BREAST ARRAY COIL

K-Number: K072874 · 2007-11-16

ApplicantInvivo
Decision Date2007-11-16
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LBS-127-16 BREAST ARRAY COIL is the device name listed in this FDA 510(k) record. The listed applicant is Invivo. It received FDA 510(k) clearance on 2007-11-16 under 510(k) number K072874. 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 LBS-127-16 BREAST ARRAY COIL?

LBS-127-16 BREAST ARRAY COIL is a medical device that received FDA 510(k) clearance on 2007-11-16. The listed applicant is Invivo. The 510(k) number is K072874.

When did LBS-127-16 BREAST ARRAY COIL receive FDA 510(k) clearance?

LBS-127-16 BREAST ARRAY COIL received FDA 510(k) clearance on 2007-11-16, under 510(k) number K072874.

Who is the listed applicant for LBS-127-16 BREAST ARRAY COIL?

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

What is the FDA product code for LBS-127-16 BREAST ARRAY COIL?

The FDA product code for LBS-127-16 BREAST ARRAY COIL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Invivo 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.

K0919021.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484K082987HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COILK082916HRB-127-32 HIGH RESOLUTION BRAIN COILK072873LBS-63-16 BREAST ARRAY COILK061952CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16

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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