Total clearances
4
2021-03-09 → 2024-12-19
Name variants in FDA filings: Imbio, Inc. / Imbio, LLC
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QIH |
Automated Radiological Image Processing Software |
Class II |
Radiology |
2 |
2024-08-30 |
| QWO |
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. |
Class II |
Radiology |
1 |
2024-12-19 |
| JAK |
System, X-Ray, Tomography, Computed |
Class II |
Radiology |
1 |
2023-06-13 |
Filings
All 510(k) clearances (4)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2024-12-19 |
K242467 |
IQ-UIP |
QWO |
Class II |
Radiology |
| 2024-08-30 |
K241847 |
Imbio PHA (4.0.0) |
QIH |
Class II |
Radiology |
| 2023-06-13 |
K230112 |
CAC Software |
JAK |
Class II |
Radiology |
| 2021-03-09 |
K203256 |
Imbio RV/LV Software |
QIH |
Class II |
Radiology |