Aspect Imaging, Ltd. is one of 508 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
Aspect Imaging, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Embrace Vision Neonatal MRI System, Embrace Neonatal MRI System, Embrace Neonatal MRI System
6
Total
6
Cleared
0
Denied
Aspect Imaging, Ltd. has 6 FDA 510(k) cleared medical devices. Based in Shoham, IL.
Latest FDA clearance: Sep 2026. Active since 2013. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Aspect Imaging, Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by MCRA and Regulatory Technology Services, LLC.
FDA 510(k) Regulatory Record - Aspect Imaging, Ltd.
6 devices
Cleared
Sep 16, 2026
Embrace Vision Neonatal MRI System
Radiology
111d
Cleared
Mar 13, 2026
Embrace Neonatal MRI System
Radiology
73d
Cleared
Jul 19, 2017
Embrace Neonatal MRI System
Radiology
107d
Cleared
Mar 01, 2016
Wrist 3
Radiology
34d
Cleared
Jan 14, 2014
M2 WRIST 2 MRI SYSTEM
Radiology
307d
Cleared
Feb 07, 2013
M2 WRIST MRI SYSTEM
Radiology
337d