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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 the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2019-06-10 under 510(k) 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. The listed applicant is Esaote, S.p.A.. The 510(k) number is K191072.

When did 7410 Ultrasound System (MyLabSigma) receive FDA 510(k) clearance?

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

Who is the listed applicant for 7410 Ultrasound System (MyLabSigma)?

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

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

The FDA product code for 7410 Ultrasound System (MyLabSigma) is IYN.

Other records listing Esaote, S.p.A. 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.

K261331I-Genius (100019400)K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

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Related Devices (Code: IYN)

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.

K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK261288Handheld Ultrasound ScannerIMGFAX CO., LTD.K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;Samsung Medison Co., Ltd.K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC

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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