Aspect Imaging, Ltd.
FDA Regulatory Profile
Aspect Imaging, Ltd. appears in FDA public data with 0 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Sep 16, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K261758 | Embrace Vision Neonatal MRI System | Sep 16, 2026 |
| K254277 | Embrace Neonatal MRI System | Mar 13, 2026 |
| K170978 | Embrace Neonatal MRI System | Jul 19, 2017 |
| K160185 | Wrist 3 | Mar 1, 2016 |
| K130692 | M2 WRIST 2 MRI SYSTEM | Jan 14, 2014 |
| K120701 | M2 WRIST MRI SYSTEM | Feb 7, 2013 |