Medical Device Manufacturer · US , New York , NY

Imagen Technologies, Inc. - FDA 510(k) Cleared Devices

6 submissions · 5 cleared · Since 2018

Recent clearances: Lung-CAD, Lung-CAD, Aorta-CAD

6
Total
5
Cleared
1
Denied

FDA 510(k) Regulatory Record - Imagen Technologies, Inc. Radiology ✕

6 devices
1-6 of 6
Cleared Oct 03, 2023
Lung-CAD
K230085 · MYN
Radiology · 265d
Cleared Sep 13, 2023
Lung-CAD
K223811 · MYN
Radiology · 267d
Cleared Sep 20, 2022
Aorta-CAD
K213353 · MYN
Radiology · 347d
Cleared Jul 20, 2021
Chest-CAD
K210666 · MYN
Radiology · 137d
Cleared Jul 30, 2020
FractureDetect (FX)
K193417 · QBS
Radiology · 234d
Not Cleared May 24, 2018
OsteoDetect
DEN180005 · QBS
Radiology · 108d
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