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FDA 510(k)

7410 Ultrasound System (MyLabSigma)

K-Number: K191072 · 2019-06-10

ApplicantEsaote, S.p.A.
Decision Date2019-06-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

7410 Ultrasound System (MyLabSigma) is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2019-06-10 under approval number K191072. 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 7410 Ultrasound System (MyLabSigma)?

7410 Ultrasound System (MyLabSigma) is a medical device that received FDA 510(k) clearance on 2019-06-10. It is manufactured by Esaote, S.p.A.. The 510(k) number is K191072.

When was 7410 Ultrasound System (MyLabSigma) approved by the FDA?

7410 Ultrasound System (MyLabSigma) received FDA 510(k) clearance on 2019-06-10, under approval number K191072.

What company makes 7410 Ultrasound System (MyLabSigma)?

7410 Ultrasound System (MyLabSigma) is manufactured by Esaote, S.p.A..

What is the FDA product code for 7410 Ultrasound System (MyLabSigma)?

The FDA product code for 7410 Ultrasound System (MyLabSigma) 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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