Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Aspect Imaging, Ltd.. It received FDA 510(k) clearance on 2017-07-19 under approval 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. It is manufactured by Aspect Imaging, Ltd.. The 510(k) number is K170978.

When was Embrace Neonatal MRI System approved by the FDA?

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

What company makes Embrace Neonatal MRI System?

Embrace Neonatal MRI System is manufactured by Aspect Imaging, Ltd..

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

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

Related Clinical Trials

NCT07602036 Type 2 Diabetes and Pregnancy a Single-arm Interventional Study NOT_YET_RECRUITING NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT04956354 The Use of Wireless Sensors in Neonatal Intensive Care ACTIVE_NOT_RECRUITING NCT06693817 Advanced Wireless Sensors for Neonatal Care in the Delivery Room RECRUITING

Other Devices by Aspect Imaging, Ltd.

K160185Wrist 3 K254277Embrace Neonatal MRI System

Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, 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.

↑