Eos Imaging: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Eos Imaging” (first 2012, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 116 days. Since 2017 the median was 117 days, against 118 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 |
|---|---|---|
| 2012 | 2 | 198 |
| 2013 | 2 | 52 |
| 2014 | 1 | 137 |
| 2015 | 2 | 72 |
| 2016 | 1 | 21 |
| 2017 | 0 | — |
| 2018 | 1 | 320 |
| 2019 | 1 | 117 |
| 2020 | 1 | 26 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 103 |
| 2024 | 3 | 190 |
| 2025 | 2 | 145 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eos Imaging took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| KPR | System, X-Ray, Stationary | 5 | 5 |
| QIH | Automated Radiological Image Processing Software | 4 | 4 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 2 |
Review panels
- Radiology (17)
Most recent Eos Imaging 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251078 | AutoDensity | QIH | 2025-11-14 | 220 |
| K251747 | VEA Align; spineEOS | QIH | 2025-08-15 | 70 |
| K233920 | EOSedge | KPR | 2024-08-06 | 237 |
| K240582 | VEA Align; spineEOS | QIH | 2024-06-25 | 116 |
| K231917 | VEA Align | QIH | 2024-01-05 | 190 |
| K232086 | spineEOS | LLZ | 2023-10-24 | 103 |
| K202394 | EOSedge | KPR | 2020-09-16 | 26 |
| K192079 | EOSedge | KPR | 2019-11-27 | 117 |
| K172346 | sterEOS Workstation | LLZ | 2018-06-19 | 320 |
| K160914 | sterEOS Workstation | LLZ | 2016-04-22 | 21 |
7 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2020-12-22.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Eos Imaging?
FDA lists 17 510(k) clearances under the applicant name “Eos Imaging” (first 2012, latest 2025), 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 Eos Imaging?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eos Imaging is 116 days. Since 2017: 117 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Eos Imaging?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 6); KPR (System, X-Ray, Stationary, 5); QIH (Automated Radiological Image Processing Software, 4).
Next steps
- See all 17 Eos Imaging clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Eos Imaging'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.