Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K220815 |
Device Name |
BrainInsight |
Applicant |
Hyperfine, Inc. |
351 New Whitfield St |
Guilford,
CT
06437
|
|
Applicant Contact |
Christine Kupchick |
Correspondent |
Hyperfine, Inc. |
351 New Whitfield St |
Guilford,
CT
06437
|
|
Correspondent Contact |
Christine Kupchick |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/21/2022 |
Decision Date | 07/19/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|