Medical Device Manufacturer · IL , Shoham

Aspect Imaging, Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2013

Recent clearances: Embrace Vision Neonatal MRI System, Embrace Neonatal MRI System, Embrace Neonatal MRI System

View 6 510(k) Devices ↓ Official Website
6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Aspect Imaging, Ltd. Radiology ✕

6 devices
1-6 of 6
Cleared Sep 16, 2026
Embrace Vision Neonatal MRI System
K261758 · LNH
Radiology · 111d
Cleared Mar 13, 2026
Embrace Neonatal MRI System
K254277 · LNH
Radiology · 73d
Cleared Jul 19, 2017
Embrace Neonatal MRI System
K170978 · LNH
Radiology · 107d
Cleared Mar 01, 2016
Wrist 3
K160185 · LNH
Radiology · 34d
Cleared Jan 14, 2014
M2 WRIST 2 MRI SYSTEM
K130692 · LNH
Radiology · 307d
Cleared Feb 07, 2013
M2 WRIST MRI SYSTEM
K120701 · LNH
Radiology · 337d
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