[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.1300]

[Page 360]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 876.1300  Ingestible telemetric gastrointestinal capsule imaging system.

    (a) Identification. An ingestible telemetric gastrointestinal 
capsule imaging system is used for visualization of the small bowel 
mucosa as an adjunctive tool in the detection of abnormalities of the 
small bowel. The device captures images of the small bowel with a 
wireless camera contained in a capsule. This device includes an 
ingestible capsule (containing a light source, camera, transmitter, and 
battery), an antenna array, a receiving/recording unit, a data storage 
device, computer software to process the images, and accessories.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance, ``Class II Special Controls Guidance Document: 
Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final 
Guidance for Industry and FDA.''

[67 FR 3433, Jan. 24, 2002]