Data / Medical devices / United States / Eigen
Eigen: FDA-registered device maker in Grass Valley, CA, United States, 5 510(k) clearances
Eigen is registered with the FDA (registration 2937707) in Grass Valley, CA, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 12, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2937707
- Address
- 13366 Grass Valley Ave, Suite A, Grass Valley, CA, United States, 95945
- Owner or operator
- Eigen (2937707)
- Roles
- Manufacturer
- First device listed
- April 22, 2009
- Registered through
- 2026
- Brand names listed
- Artemis, Artemis 2 HD, Artemis-TPOS, ProFuse, ProFuse / ProFuse CAD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | QTZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 12, 2023 | K222222 | Artemis, Artemis TPO, Artemis MX | QTZ | Substantially Equivalent | Eigen | accessdata.fda.gov |
| November 21, 2018 | K173744 | ProFuse CAD | LLZ | Substantially Equivalent | Eigen | accessdata.fda.gov |
| October 21, 2016 | K162474 | Artemis | LLZ | Substantially Equivalent | Eigen | accessdata.fda.gov |
| April 6, 2012 | K120187 | MULTI-MODALITY IMAGE FUSION | LLZ | Substantially Equivalent | Igt, LLC Dba Eigen | accessdata.fda.gov |
| May 1, 2008 | K081093 | 3-D IMAGING WORKSTATION | LLZ | Substantially Equivalent | Eigen, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
- All makers of Unit, Cryosurgical, Accessories
Updated October 12, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.