[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.2980]

[Page 455]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884_OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart C_Obstetrical and Gynecological Monitoring Devices
 
Sec. 884.2980  Telethermographic system.

    (a) Telethermographic system intended for adjunctive diagnostic 
screening for detection of breast cancer or other uses--(1) 
Identification. A telethermographic system for adjunctive diagnostic 
screening for detection of breast cancer or other uses is an 
electrically powered device with a detector that is intended to measure, 
without touching the patient's skin, the self-emanating infrared 
radiation that reveals the temperature variations of the surface of the 
body. This generic type of device may include signal analysis and 
display equipment, patient and equipment supports, component parts, and 
accessories.
    (2) Classification. Class I (general controls).
    (b) Telethermographic system intended for use alone in diagnostic 
screening for detection of breast cancer or other uses--(1) 
Identification. A telethermographic system for use as the sole 
diagnostic screening tool for detection of breast cancer or other uses 
is an electrically powered device with a detector that is intended to 
measure, without touching the patient's skin, the self-emanating 
infrared radiation that reveals the temperature variations of the 
surface of the body. This generic type of device may include signal 
analysis and display equipment, patient and equipment supports, 
component parts, and accessories.
    (2) Classification. Class III.
    (3) Date PMA or notice of completion of a PDP is required. As of the 
enactment date of the amendments, May 28, 1976, an approval under 
section 515 of the act is required before the device described in 
paragraph (b)(1) may be commercially distributed. See Sec. 884.3.

[53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48440, Nov. 20, 1990; 66 
FR 46953, Sept. 10, 2001]

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