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FDA 510(k)

MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE

K-Number: K052704 · 2005-11-03

ApplicantInvivo Corp.
Decision Date2005-11-03
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corp.. It received FDA 510(k) clearance on 2005-11-03 under 510(k) number K052704. 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 MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE?

MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 2005-11-03. The listed applicant is Invivo Corp.. The 510(k) number is K052704.

When did MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE receive FDA 510(k) clearance?

MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE received FDA 510(k) clearance on 2005-11-03, under 510(k) number K052704.

Who is the listed applicant for MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE?

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

What is the FDA product code for MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE?

The FDA product code for MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE is MOS.

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Other records listing Invivo Corp. 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.

K090785MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214K052497NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-AK051512CAC-127-8 CARDOAC ARRAY COIL

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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