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424
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277
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Manufacturers
US
Imbio, LLC
Medical Device Manufacturer
·
US , Minneapolis , MN
Imbio, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2014
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Imbio, LLC
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 09, 2021
Imbio RV/LV Software
K203256
·
QIH
Radiology
·
125d
Cleared
Mar 16, 2018
Imbio Segmentation Editing Tool software
K180129
·
LLZ
Radiology
·
58d
Cleared
Sep 17, 2014
Lung Density Analysis
K141069
·
JAK
Radiology
·
146d
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3
Radiology
3