Imbio, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Imbio, Inc.” (first 2014, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 123 days. Since 2017 the median was 121 days, against 130 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 146 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 58 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 125 |
| 2022 | 0 | — |
| 2023 | 1 | 147 |
| 2024 | 2 | 93 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Imbio, Inc. took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| QWO | Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. | 1 | 1 |
Review panels
- Radiology (6)
Most recent Imbio, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242467 | IQ-UIP | QWO | 2024-12-19 | 121 |
| K241847 | Imbio PHA (4.0.0) | QIH | 2024-08-30 | 65 |
| K230112 | CAC Software | JAK | 2023-06-13 | 147 |
| K203256 | Imbio RV/LV Software | QIH | 2021-03-09 | 125 |
| K180129 | Imbio Segmentation Editing Tool software | LLZ | 2018-03-16 | 58 |
| K141069 | Lung Density Analysis | JAK | 2014-09-17 | 146 |
Recalls
openFDA lists no recalls under a recalling firm named Imbio, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Imbio, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03087617: Personalized Smoking Cessation Tool Based on Patient Lung CT Image (Completed, started 2018-10-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Imbio, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Imbio, Inc.” (first 2014, latest 2024), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Imbio, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imbio, Inc. is 123 days. Since 2017: 121 days, versus 130 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Imbio, Inc.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 2); QIH (Automated Radiological Image Processing Software, 2); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 6 Imbio, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Imbio, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.