Hyperfine Research, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Hyperfine Research, Inc. makes
Hyperfine Research, Inc. manufactures portable magnetic resonance imaging (MRI) systems designed for point-of-care use, including the POC MRI Scanner System and the Lucy device. These systems are intended for rapid, on-site imaging of soft tissues and organs, enabling real-time diagnostic capabilities outside traditional radiology settings. BrainInsight is a software tool integrated with these systems to assist in image analysis and interpretation.
The company’s MRI devices are classified as Class II under US regulations and are listed via the FDA’s 510(k) pathway. These products are intended for use in the United States, where they are subject to compliance with the Federal Food, Drug, and Cosmetic Act.
Catalogue
- Regimes: 510(k) Registry: 510(k)
BrainInsight Ref K202414
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hyperfine Research, Inc. have in the registry?
The registry currently lists 3 devices for Hyperfine Research, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hyperfine Research, Inc.'s devices?
Among its 3 most recently registered devices, Hyperfine Research, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Hyperfine Research, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Hyperfine Research, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hyperfine Research, Inc. in the registry?
The most recently registered devices listed for Hyperfine Research, Inc. include Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System, BrainInsight and Lucy Point-of-Care Magnetic Resonance Imaging Device.