Eigen - FDA 510(k) Cleared Devices

Cleared Oct 12, 2023

Artemis, Artemis TPO, Artemis MX

K222222 · QTZ

Radiology · 444d

Cleared Nov 21, 2018

ProFuse CAD

K173744 · LLZ

Radiology · 349d

Cleared Oct 21, 2016

Artemis

K162474 · LLZ

Radiology · 45d

Cleared Jan 26, 2007

EIGEN DSA 2000

K063846 · LLZ

Radiology · 30d

Cleared Apr 07, 1994

DIGITAL DISK RECORDER

K933115 · LMB

Radiology · 286d

Cleared Nov 23, 1992

DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT

K924164 · JAA

Radiology · 96d

Cleared Oct 21, 1992

DIGITAL FLUORO STORE

K923585 · JAA

Radiology · 93d

Cleared Sep 23, 1991

DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES

K913012 · JAA

Radiology · 77d

Cleared Jan 25, 1991

DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES

K905111 · JAA

Radiology · 73d

Cleared Nov 07, 1990

PSC-1 W/OTHER NUMERICAL

K903821 · JAA

Radiology · 79d

Cleared Aug 03, 1990

DIGITAL PHOTOSPOT

K902927 · JAA

Radiology · 31d

Cleared Jul 02, 1990

DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)

K901956 · LMB

Radiology · 62d

Cleared Mar 14, 1989

SC-1000 WITH SUFFIXES (SCAN CONVERTER)

K890745 · JAA

Radiology · 29d

Cleared Aug 19, 1988

HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP

K882175 · JAA

Radiology · 87d

Cleared Aug 11, 1988

VTR-12

K882176 · JAA

Radiology · 79d

Cleared Jun 28, 1988

HR-1000 W/SUFFIXES (B,C OR D)

K882184 · LMB

Radiology · 35d