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Imbio, LLC
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
6
Inspections
2
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K242467
IQ-UIP
December 19, 2024
K241847
Imbio PHA (4.0.0)
August 30, 2024
K230112
CAC Software
June 13, 2023
K203256
Imbio RV/LV Software
March 9, 2021
K180129
Imbio Segmentation Editing Tool software
March 16, 2018
K141069
Lung Density Analysis
September 17, 2014