Device Classification Name |
Radiological Computer-Assisted Prioritization Software For Lesions
|
510(k) Number |
K222268 |
Device Name |
Annalise Enterprise CXR Triage Trauma |
Applicant |
Annalise-AI Pty Ltd |
Level P, 24 Campbell St |
Sydney,
AU
2000
|
|
Applicant Contact |
Minta Chen |
Correspondent |
Annalise-AI Pty Ltd |
Level P, 24 Campbell St |
Sydney,
AU
2000
|
|
Correspondent Contact |
Haylee Bosshard |
Regulation Number | 892.2080
|
Classification Product Code |
|
Date Received | 07/28/2022 |
Decision Date | 03/28/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|