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FDA 510(k)

O-Scan

K-Number: K183685 · 2019-01-22

ApplicantEsaote, S.p.A.
Decision Date2019-01-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

O-Scan 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 2019-01-22 under 510(k) number K183685. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O-Scan?

O-Scan is a medical device that received FDA 510(k) clearance on 2019-01-22. The listed applicant is Esaote, S.p.A.. The 510(k) number is K183685.

When did O-Scan receive FDA 510(k) clearance?

O-Scan received FDA 510(k) clearance on 2019-01-22, under 510(k) number K183685.

Who is the listed applicant for O-Scan?

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 O-Scan?

The FDA product code for O-Scan is LNH.

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: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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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