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The Tracker / September 2026 / K261758

510(k) cleared

Embrace Vision Neonatal MRI System

Aspect Imaging, Ltd. · Sep 16, 2026 · K261758

FDA cleared the Embrace Vision Neonatal MRI System from Aspect Imaging, Ltd. on Sep 16, 2026 under K261758, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 28, 2026. The decision came 111 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Aspect Imaging, Ltd. has one other decision in the tracker over the last 12 months: K254277 (Embrace Neonatal MRI System).

Questions & Answers

What did FDA clear under K261758?

K261758 is the FDA 510(k) for Embrace Vision Neonatal MRI System, submitted by Aspect Imaging, Ltd.. FDA's decision date was Sep 16, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the Embrace Vision Neonatal MRI System?

Aspect Imaging, Ltd., based in Shoham, is the applicant of record for K261758.

How long did the K261758 review take?

FDA received the submission on May 28, 2026 and issued its decision on Sep 16, 2026, 111 days later.

← All decisions in September 2026

Sources