Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K212690 |
Device Name |
qXR-BT |
Applicant |
Qure.ai Technologies |
Level 7, Commerz II, International Business park, |
Oberoi Garden City, Goregaon(E) |
Mumbai,
IN
400063
|
|
Applicant Contact |
Bunty Kundnani |
Correspondent |
Qure.ai Technologies |
Level 7, Commerz II, International Business park, |
Oberoi Garden City, Goregaon(E) |
Mumbai,
IN
400063
|
|
Correspondent Contact |
Bunty Kundnani |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/25/2021 |
Decision Date | 12/21/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|