Fujifilm - ED-530XT
by Fujifilm


The Fujifilm duodenoscope is designed to provide advanced handling and reduced fatigue to the physician. Lightweight design, redesigned elevator function, and an enclosed elevator channel allow for smooth elevator operation.
[list] [*] Redesigned suction and elevator system [*] Super image screen for superior visualization [*] Unsurpassed handling and operation [/list]
| Length | 1550 mm |
[list] [*] Viewing direction: Lateral (8°retro) [*] Observation range: 4 - 60mm [*] Field of view: 100° [*] Distal end diameter: 13.1mm [*] Flexible portion diameter: 11.5mm [*] Bending capability: > Up/Down - 130°/90° > Left/Right - 90°/110° [*] Forcep channel diameter: 4.2mm [*] Working length: 1,250mm [*] Recommended System: EPX-4440HD, EPX-4400HD, EPX-4400 (Ver 1.199 or later) [/list]
The FDA is issuing this communication to provide updated status information about FDA clearance of Fujifilm's ED-530XT and to amplify Fujifilm's Urgent Medical Device Correction and Removal notice, issued on July 21, 2017.
Fuji informed the Agency of its plans to remove legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use.