Imbio, Inc.
FDA Regulatory Profile
Imbio, Inc. appears in FDA public data with 0 recalls, 6 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Dec 19, 2024.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242467 | IQ-UIP | Dec 19, 2024 |
| K241847 | Imbio PHA (4.0.0) | Aug 30, 2024 |
| K230112 | CAC Software | Jun 13, 2023 |
| K203256 | Imbio RV/LV Software | Mar 9, 2021 |
| K180129 | Imbio Segmentation Editing Tool software | Mar 16, 2018 |
| K141069 | Lung Density Analysis | Sep 17, 2014 |