Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

3T HD BREAST ARRAY

K-Number: K052585 · 2005-10-04

ApplicantUsa Instruments, Inc.
Decision Date2005-10-04
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3T HD BREAST ARRAY is the device name listed in this FDA 510(k) record. The listed applicant is Usa Instruments, Inc.. It received FDA 510(k) clearance on 2005-10-04 under 510(k) number K052585. 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 3T HD BREAST ARRAY?

3T HD BREAST ARRAY is a medical device that received FDA 510(k) clearance on 2005-10-04. The listed applicant is Usa Instruments, Inc.. The 510(k) number is K052585.

When did 3T HD BREAST ARRAY receive FDA 510(k) clearance?

3T HD BREAST ARRAY received FDA 510(k) clearance on 2005-10-04, under 510(k) number K052585.

Who is the listed applicant for 3T HD BREAST ARRAY?

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

What is the FDA product code for 3T HD BREAST ARRAY?

The FDA product code for 3T HD BREAST ARRAY 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 Usa Instruments, 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.

K052916USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAYK0525841.5T 12 CHANNEL BODY ARRAYK0526211.5T 16 CHANNEL BRAIN-SPINE ARRAY COILK050728OPEN BREAST COIL (OBC) WITH BIOPSY PLATESK042342MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COILK0421863.0T 8-CHANNEL CTL SPINE ARRAY

View all 64 devices →

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.

↑