Fujifilm Medical Systems U.S.A., Inc.

All lots/serial numbers

Gastroenterology-Urology Devices

2

No

Nationwide

FUJINON ED-530XT. || This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

will be entered.

Gastroenterology-Urology Devices

2

No

US Nationwide Distribution

Fujifilm Endoscope || Models || ED-250XL5 || ED-250XT5 || ED-450XT5 || ED-450XL5 || Product Usage: || This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

For Manual Code 202B1259902B, 140417-3.0-DT-US2 - 157 manuals were distributed For Manual Code 202B1237697D, 140408-5.0-DT-US2 - 103 manuals were distributed

Gastroenterology-Urology Devices

2

No

US Nationwide Distribution

Fujifilm Endoscope || Model ED-530XT || Product Usage: || This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

1U881A131 1U88A1A145 3U881A005

Gastroenterology-Urology Devices

2

No

US Distribution to : AL, HI and MO

Ultrasonic Endoscope || Model Number EG-530UT || A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs

All distribution dates :3/2003-4/2016

Gastroenterology-Urology Devices

2

No

Nationwide Distribution.

Endoscope || ED-450XL5 || Operation Manual: Cleaning, Disinfection and Storage