Years away - really????? Get ready to be crushed. 510K is in
n Device'Name: XCFJHI60AY2L
m Common Name: COLONOVIDEOSCOPE
* Manufacturer: Aizu Olympu s Co., Ltd.
500 Aza-Muranishi, Qoaza-lidera, Monden-cha,
Aiuikana-shi, Fukushima, Japan 965-8520
Establishment Registration No.: 9610595
* 510(k) No. K051645
4 Device Description
The CF-Y0023-ULI Colonovideoscope is a flexible video endoscope used for
endoscopic diagnosis and treatment within the colon . The CF-Y0023-ULI
Colonovideoscope is basically identical to the predicate device, Olympus
XCF-H16OAY2L Colonovideoscape, hereinafter referred to as
XCF-H16OAY2L in intended use, specifications, performance. The optical
system of the CF-Y0023-ULI is a charge coupled device (CCD) based
system, allowing endoscopic image display on a video monitor.
The major differences of the subjett CF-Y0023-UlI Colonovideoscope from
the predicate XCF-H160AV2L device are as follows:
-The number of objective lens andithe width of the field of view for the
subject and predicate devices dilier.. (CF-Y0023--LI:140 0 (forward view) and
141- 2330 (side view). XCF-H-16pA~Y2L:17O0 (forward view))
-The shape of distal ends differ.
-The layout of the light guide lens differ.
-The number of air/water nozzles differ.( CF-Y0023-LJI:n=3,
XCF-Hl6OAY2L:n1l)
The new colonovideoscope CF-Y0023-ULI has both 140 degree forward view
and 141-233 degree side view. Both forward view and side view are focused
on one OCO, and the user can p1bserve both 140 degree forward view and
141-233 degree side view at once