Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Applications for Medical Device Product Code "QDQ"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K220105
DeepHealth, Inc.
Saige-Dx
05/12/2022
K201019
Hologic, Inc.
Genius AI Detection
11/18/2020
K221449
Hologic, Inc.
Genius AI Detection 2.0
10/06/2022
K230096
Hologic, Inc.
Genius AI Detection 2.0 with CC-MLO Correlation
05/23/2023
K182373
iCAD Inc.
PowerLook Tomo Detection V2 Software
12/06/2018
K191994
iCAD Inc.
ProFound AI Software V2.1
10/04/2019
K203822
iCAD Inc.
ProFound AI Software V3.0
03/12/2021
K211678
Lunit Inc.
Lunit INSIGHT MMG
11/17/2021
K212783
ScanMed, LLC
ProstatID
07/08/2022
K192287
Screenpoint Medical B.V.
Transpara
12/10/2019
K193229
ScreenPoint Medical B.V.
Transpara
03/05/2020
K210404
ScreenPoint Medical B.V.
Transpara 1.7.0
06/02/2021
K221347
ScreenPoint Medical B.V.
Transpara 1.7.2
08/03/2022
K181704
ScreenPoint Medical BV
Transpara
11/21/2018
K210670
TaiHao Medical Inc.
BU-CAD
12/21/2021
K192854
Therapixel
MammoScreen
03/25/2020
K211541
Therapixel
MammoScreen 2.0
11/26/2021
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact