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)

MODIFICATION TO ARTOSCAN M

K-Number: K010057 · 2001-02-02

ApplicantBiosound Esaote, Inc.
Decision Date2001-02-02
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ARTOSCAN M is the device name listed in this FDA 510(k) record. The listed applicant is Biosound Esaote, Inc.. It received FDA 510(k) clearance on 2001-02-02 under 510(k) number K010057. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ARTOSCAN M?

MODIFICATION TO ARTOSCAN M is a medical device that received FDA 510(k) clearance on 2001-02-02. The listed applicant is Biosound Esaote, Inc.. The 510(k) number is K010057.

When did MODIFICATION TO ARTOSCAN M receive FDA 510(k) clearance?

MODIFICATION TO ARTOSCAN M received FDA 510(k) clearance on 2001-02-02, under 510(k) number K010057.

Who is the listed applicant for MODIFICATION TO ARTOSCAN M?

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

What is the FDA product code for MODIFICATION TO ARTOSCAN M?

The FDA product code for MODIFICATION TO ARTOSCAN M is LNH.

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 Biosound Esaote, 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.

K023255TECHNOS MP, MODEL AU6K014168AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)K020164E-SCAN XQK012728E-SCAN MRI SYSTEMK0104057230 ULTRASOUND IMAGING SYSTEM WITH TEIK001894MODIFICATION TO E-SCAN

View all 20 devices →

Related Devices (Code: LNH)

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.

K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K261283APERTO Lucent MRI SystemFujifilm CorporationK260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems

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.

↑