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FDA 510(k)

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

K-Number: K253288 · 2026-04-06

ApplicantEsaote, S.p.A.
Decision Date2026-04-06
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 2026-04-06 under approval number K253288. 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 2026-04-06. It is manufactured by Esaote, S.p.A.. The 510(k) number is K253288.

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 2026-04-06, under approval number K253288.

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.

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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

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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.

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