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FDA 510(k)

Embrace Neonatal MRI System

K-Number: K170978 · 2017-07-19

ApplicantAspect Imaging, Ltd.
Decision Date2017-07-19
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Embrace Neonatal MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Aspect Imaging, Ltd.. It received FDA 510(k) clearance on 2017-07-19 under 510(k) number K170978. 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 Embrace Neonatal MRI System?

Embrace Neonatal MRI System is a medical device that received FDA 510(k) clearance on 2017-07-19. The listed applicant is Aspect Imaging, Ltd.. The 510(k) number is K170978.

When did Embrace Neonatal MRI System receive FDA 510(k) clearance?

Embrace Neonatal MRI System received FDA 510(k) clearance on 2017-07-19, under 510(k) number K170978.

Who is the listed applicant for Embrace Neonatal MRI System?

The FDA 510(k) record lists Aspect Imaging, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Embrace Neonatal MRI System?

The FDA product code for Embrace Neonatal MRI System is LNH.

Other records listing Aspect Imaging, Ltd. 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.

K254277Embrace Neonatal MRI SystemK160185Wrist 3

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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