Elucid Bioimaging, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Elucid Bioimaging, Inc.” (first 2017, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 106 days. Since 2017 the median was 106 days, against 127 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 |
|---|---|---|
| 2017 | 1 | 203 |
| 2018 | 1 | 51 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 29 |
| 2023 | 0 | — |
| 2024 | 1 | 106 |
| 2025 | 0 | — |
| 2026 | 1 | 107 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Elucid Bioimaging, Inc. took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 5 | 5 |
Review panels
- Radiology (5)
Most recent Elucid Bioimaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261855 | Elucid PlaqueIQ | LLZ | 2026-09-18 | 107 |
| K241524 | Elucid PlaqueIQ | LLZ | 2024-09-12 | 106 |
| K221463 | ElucidVivo A.3 | LLZ | 2022-06-17 | 29 |
| K183012 | vascuCAP | LLZ | 2018-12-21 | 51 |
| K163071 | vascuCAP | LLZ | 2017-05-24 | 203 |
Recalls
openFDA lists no recalls under a recalling firm named Elucid Bioimaging, 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 Elucid Bioimaging, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04439643: Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD) (Completed, started 2020-02-05)
- NCT05524896: Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography (Completed, started 2017-01-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Elucid Bioimaging, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Elucid Bioimaging, Inc.” (first 2017, latest 2026), across 1 product code 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 Elucid Bioimaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elucid Bioimaging, Inc. is 106 days. Since 2017: 106 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Elucid Bioimaging, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 5).
Next steps
- See all 5 Elucid Bioimaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Elucid Bioimaging, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.