FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR— 510(k) K102466

Name: FDA 510(k) clearance K102466
Creator: U.S. Food and Drug Administration
Published: 2011-05-25

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K102466 for FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR, Substantially Equivalent on 2011-05-25. Applicant: Fujinon, Inc.. Device class: 2.

Clearance details

Applicant: Fujinon, Inc.
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2010-08-30
Decision date: 2011-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FET

view all

K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB2026-09-10
K261880 — FUJIFILM Processor EP-8000; Balloon Controller PB-30; Endoscopy Support Program EW10-VM012026-07-02
K261260 — HD Camera Head OLYMPUS CH-S200-08-LB2026-06-24
K251734 — ProVee Video Processing Unit (PV-003)2025-09-24
K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K)2025-08-11

More clearances from Fujinon, Inc.

view all

K120446 — FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT22012-08-13
K112391 — FUJINON COLONOSCOPES2012-07-26
K111243 — FUJINON ULTRASONIC PROCESSOR2011-05-16
K091773 — FUJINON STERILE OVERTUBES2009-08-07
K090116 — FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B152009-04-22

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.