Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System— 510(k) K201722
Substantially EquivalentHyperfine Research, Inc.
FDA 510(k) clearance K201722 for Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System, Substantially Equivalent on 2020-08-11. Applicant: Hyperfine Research, Inc..
Clearance details
- Applicant
- Hyperfine Research, Inc.
- Product code
- Code LNH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guildford, CT, US
Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.