# Hyperfine Research, Inc.

- Location (FDA's records): Guildford, CT
- FDA decisions: 3 (2020–2021): 3 510(k) clearances
- Product codes: LNH (2), LLZ (1)
- 510(k) review time since 2016: median 136 days, against 121 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 6 (1 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
- Aspect Imaging, Ltd.: 1 (https://510kreport.com/company/aspect-imaging)
- Cortechs Labs, Inc.: 1 (https://510kreport.com/company/cortechs-labs)

## Firms that cite its devices most
- Hyperfine, Inc.: 3 (https://510kreport.com/company/hyperfine)
- Neuro42, Inc.: 1 (https://510kreport.com/company/neuro42)
- Jiangsu Lici Medical Device Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-lici-medical-device)

## Its most-cited devices
- K192002: Lucy Point-of-Care Magnetic Resonance Imaging Device (2020), cited by 3
- K201722: Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (2020), cited by 2
- K202414: BrainInsight (2021), cited by 1

## Recent decisions
- K202414: BrainInsight (Jan 7, 2021)
- K201722: Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (Aug 11, 2020)
- K192002: Lucy Point-of-Care Magnetic Resonance Imaging Device (Feb 6, 2020)

Source page: https://510kreport.com/company/hyperfine-research