Medical Device Manufacturer · US , Nevada City , CA

Eigen - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1988

Total

Cleared

Denied

Eigen has 16 FDA 510(k) cleared radiology devices. Based in Nevada City, US.

Last cleared in 2023. Active since 1988.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Eigen

16 devices

1-12 of 16

Cleared Oct 12, 2023

Artemis, Artemis TPO, Artemis MX

DIGITAL DISK RECORDER

K933115 · LMB

Radiology · 286d

Cleared Nov 23, 1992

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

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

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

K901956 · LMB

Radiology · 62d

Eigen - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by Eigen

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