Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K223623 |
Device Name |
SubtleMR (2.3.x) |
Applicant |
Subtle Medical Inc. |
883 Santa Cruz Ave Suite 205 |
Menlo Park,
CA
94025
|
|
Applicant Contact |
Ajit Shankaranarayanan |
Correspondent |
Enzyme Corporation |
611 Gateway Blvd #120 |
South San Francisco,
CA
94080
|
|
Correspondent Contact |
Jared Seehafer |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/05/2022 |
Decision Date | 05/11/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|