Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K243705 |
Device Name |
Saige-Density (2.5.0) |
Applicant |
DeepHealth, Inc |
212 Elm Street |
Somerville,
MA
02144
|
|
Applicant Contact |
B. Nathan Hunt |
Correspondent |
DeepHealth, Inc |
212 Elm Street |
Somerville,
MA
02144
|
|
Correspondent Contact |
B. Nathan Hunt |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/29/2024 |
Decision Date | 12/19/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|