Medical Device Manufacturer · US , Nevada City , CA

Eigen

16 submissions · 16 cleared · Since 1988
16
Total
16
Cleared
0
Denied

Eigen — FDA 510(k) Submissions

Eigen has submitted 16 FDA 510(k) premarket notifications since 1988, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Fluoroscopic, Image-intensified, System, Image Processing, Radiological, Device, Digital Image Storage, Radiological, Radiological Image Processing Software For Ablation Therapy Planning And Evaluation . Use the specialty filter in the sidebar to narrow results.

16 devices
1–12 of 16
Artemis, Artemis TPO, Artemis MX
K222222 · QTZ Radiological Image... · Radiology
Oct 2023 444d
ProFuse CAD
K173744 · LLZ System, Image Processing,... · Radiology
Nov 2018 349d
Artemis
K162474 · LLZ System, Image Processing,... · Radiology
Oct 2016 45d
EIGEN DSA 2000
K063846 · LLZ System, Image Processing,... · Radiology
Jan 2007 30d
DIGITAL DISK RECORDER
K933115 · LMB Device, Digital Image... · Radiology
Apr 1994 286d
DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT
K924164 · JAA System, X-ray,... · Radiology
Nov 1992 96d
DIGITAL FLUORO STORE
K923585 · JAA System, X-ray,... · Radiology
Oct 1992 93d
DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES
K913012 · JAA System, X-ray,... · Radiology
Sep 1991 77d
DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES
K905111 · JAA System, X-ray,... · Radiology
Jan 1991 73d
PSC-1 W/OTHER NUMERICAL
K903821 · JAA System, X-ray,... · Radiology
Nov 1990 79d
DIGITAL PHOTOSPOT
K902927 · JAA System, X-ray,... · Radiology
Aug 1990 31d
DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)
K901956 · LMB Device, Digital Image... · Radiology
Jul 1990 62d
Filters
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