Medical Device Manufacturer · US , Washington , DC

Fujinon, Inc. - FDA 510(k) Cleared Devices

30 submissions · 30 cleared · Since 1990

Recent clearances: FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2, FUJINON COLONOSCOPES, FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR

30

Total

30

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fujinon, Inc. Radiology ✕

5 devices

1-5 of 5

Cleared Aug 13, 2012

FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2

Radiology · 181d

Cleared May 16, 2011

FUJINON ULTRASONIC PROCESSOR

Radiology · 13d

Cleared Mar 01, 2007

FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700

Radiology · 64d

Cleared Dec 12, 1997

ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY)

Radiology · 228d

Cleared May 22, 1990

FUJINON EDU SYSTEM

Radiology · 299d