Device Classification Name |
Radiological Computer-Assisted Prioritization Software For Lesions
|
510(k) Number |
K211803 |
Device Name |
HealthPPT |
Applicant |
Zebra Medical Vision Ltd. |
Shefayim Commercial Center, PO Box 25 |
Sefayim,
IL
6099000
|
|
Applicant Contact |
Shlomit Cymbalista |
Correspondent |
Zebra Medical Vision Ltd. |
Shefayim Commercial Center, PO Box 25 |
Sefayim,
IL
6099000
|
|
Correspondent Contact |
Shlomit Cymbalista |
Regulation Number | 892.2080
|
Classification Product Code |
|
Date Received | 06/11/2021 |
Decision Date | 12/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|