Eigen: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Eigen” (first 1988, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 45 |
| 2017 | 0 | — |
| 2018 | 1 | 349 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 444 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eigen took a median 396 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 9 | 9 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| LMB | Device, Digital Image Storage, Radiological | 3 | 3 |
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | 1 | 1 |
Review panels
- Radiology (16)
Most recent Eigen 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222222 | Artemis, Artemis TPO, Artemis MX | QTZ | 2023-10-12 | 444 |
| K173744 | ProFuse CAD | LLZ | 2018-11-21 | 349 |
| K162474 | Artemis | LLZ | 2016-10-21 | 45 |
| K063846 | EIGEN DSA 2000 | LLZ | 2007-01-26 | 30 |
| K933115 | DIGITAL DISK RECORDER | LMB | 1994-04-07 | 286 |
| K924164 | DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT | JAA | 1992-11-23 | 96 |
| K923585 | DIGITAL FLUORO STORE | JAA | 1992-10-21 | 93 |
| K913012 | DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES | JAA | 1991-09-23 | 77 |
| K905111 | DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES | JAA | 1991-01-25 | 73 |
| K903821 | PSC-1 W/OTHER NUMERICAL | JAA | 1990-11-07 | 79 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Eigen.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Eigen Video (4 510(k)s)
- Eigen, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Eigen?
FDA lists 16 510(k) clearances under the applicant name “Eigen” (first 1988, latest 2023), 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 Eigen?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eigen is 78 days.
Which FDA product codes appear under Eigen?
The most frequent FDA product codes under this applicant name are JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 9); LLZ (System, Image Processing, Radiological, 3); LMB (Device, Digital Image Storage, Radiological, 3).
Next steps
- See all 16 Eigen clearances with predicates and recalls
- Run predicate analysis for product code JAA, Eigen'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.