Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K192002 |
Device Name |
Lucy Point-of-Care Magnetic Resonance Imaging Device |
Applicant |
Hyperfine Research, Inc. |
530 Old Whitfield Street |
Guilford,
CT
06437
|
|
Applicant Contact |
Brian Sawin |
Correspondent |
Hyperfine Research, Inc. |
530 Old Whitfield Street |
Guilford,
CT
06437
|
|
Correspondent Contact |
Brian Sawin |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/26/2019 |
Decision Date | 02/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|