# Aspect Imaging, Ltd.

- Location (FDA's records): Industrial Area Hevel Modi’In., IL
- FDA decisions: 6 (2013–2026): 6 510(k) clearances
- Product codes: LNH (6)
- 510(k) review time since 2016: median 90 days, against 117 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 6 (5 its own); citations of its devices by later devices: 8 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Oni, Inc.: 1 (https://510kreport.com/company/oni)

## Firms that cite its devices most
- Hyperfine Research, Inc.: 1 (https://510kreport.com/company/hyperfine-research)
- Eyas Medical Imaging, Inc.: 1 (https://510kreport.com/company/eyas-medical-imaging)
- Jiangsu Lici Medical Device Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-lici-medical-device)

## Its most-cited devices
- K170978: Embrace Neonatal MRI System (2017), cited by 4
- K254277: Embrace Neonatal MRI System (2026), cited by 1
- K120701: M2 Wrist Mri System (2013), cited by 1
- K130692: M2 Wrist 2 Mri System (2014), cited by 1
- K160185: Wrist 3 (2016), cited by 1

## Recent decisions
- 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)

Source page: https://510kreport.com/company/aspect-imaging