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)

MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM

K-Number: K061755 · 2006-08-07

ApplicantEsaote Europe B.V.
Decision Date2006-08-07
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Esaote Europe B.V.. It received FDA 510(k) clearance on 2006-08-07 under 510(k) number K061755. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM?

MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-07. The listed applicant is Esaote Europe B.V.. The 510(k) number is K061755.

When did MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM receive FDA 510(k) clearance?

MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM received FDA 510(k) clearance on 2006-08-07, under 510(k) number K061755.

Who is the listed applicant for MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM?

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

What is the FDA product code for MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM?

The FDA product code for MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM is IYO.

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 Esaote Europe B.V. 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.

K161168MyLabSix Ultrasound SystemK101605MYLABONE ULTRASOUND SYSTEMK083882MYLABFIVEK070903MYLAB40K062598IMT.LAB SOFTWARE

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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.

↑