# Eigen

- Location (FDA's records): Nevada City, CA
- FDA decisions: 18 (1988–2023): 18 510(k) clearances
- Names in FDA's records: Eigen (16); Eigen, LLC (2)
- Product codes: JAA (9), LLZ (5), LMB (3), QTZ (1)
- 510(k) review time since 2016: median 349 days, against 105 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 12 (6 its own); citations of its devices by later devices: 15 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Icad, Inc.: 2 (https://510kreport.com/company/icad)
- Invivo Corporation: 1 (https://510kreport.com/company/invivo)
- Biotronics3D, Ltd.: 1 (https://510kreport.com/company/biotronics3d)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Mri Devices Corp.: 1 (https://510kreport.com/company/mri-devices)

## Firms that cite its devices most
- Multimodal Imaging Services Corporation (Dba Healthlytix): 1 (https://510kreport.com/company/multimodal-imaging-services-dba-healthlytix)
- Jet Soft Srl: 1 (https://510kreport.com/company/jet-soft)
- Nesa Medtech Private Limited: 1 (https://510kreport.com/company/nesa-medtech-private)
- Sentinelle Medical, Inc.: 1 (https://510kreport.com/company/sentinelle-medical)
- Koelis: 1 (https://510kreport.com/company/koelis)
- UC-CARE, Ltd.: 1 (https://510kreport.com/company/uc-care)
- Focal Healtcare, Inc.: 1 (https://510kreport.com/company/focal-healtcare)
- Augment Intelligent Medical System (China) Co., Ltd.: 1 (https://510kreport.com/company/augment-intelligent-medical-system-china)

## Its most-cited devices
- K081093: 3-D Imaging Workstation (2008), cited by 9
- K901956: Digital 8 W/Other Numerical Suffixes (1-9, Etc.) (1990), cited by 2
- K162474: Artemis (2016), cited by 2
- K063846: Eigen Dsa 2000 (2007), cited by 1
- K173744: ProFuse CAD (2018), cited by 1

## Recent decisions
- K222222: Artemis, Artemis TPO, Artemis MX (Oct 12, 2023)
- K173744: ProFuse CAD (Nov 21, 2018)
- K162474: Artemis (Oct 21, 2016)
- K082341: DSA 2000EX (Aug 29, 2008)
- K081093: 3-D Imaging Workstation (May 1, 2008)
- K063846: Eigen Dsa 2000 (Jan 26, 2007)
- K933115: Digital Disk Recorder (Apr 7, 1994)
- K924164: Digital Disk Recorder W/Dualpath Archive/30-60 Opt (Nov 23, 1992)

Source page: https://510kreport.com/company/eigen