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

FDA 510(k)

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

K-Number: K241671 · 2025-05-16

ApplicantEsaote, S.p.A.
Decision Date2025-05-16
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2025-05-16 under approval number K241671. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is a medical device that received FDA 510(k) clearance on 2025-05-16. It is manufactured by Esaote, S.p.A.. The 510(k) number is K241671.

When was 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) approved by the FDA?

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) received FDA 510(k) clearance on 2025-05-16, under approval number K241671.

What company makes 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is manufactured by Esaote, S.p.A..

What is the FDA product code for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

The FDA product code for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is IYN.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT06559891 THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING

Other Devices by Esaote, S.p.A.

K161973G-scan Brio, S-scan K162290MyLabSix CrystaLine K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System K161238S-scan K1532776200 Ultrasound System and 6250 Ultrasound System K153039MRI Dynamic Analysis Plus

View all 24 devices →

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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.

↑