[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: 21CFR884.2982]

[Page 436-437]
 
                        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. 884.2982  Liquid crystal thermographic system.

    (a) A nonelectrically powered or an AC-powered liquid crystal 
thermographic system intended for adjunctive use in diagnostic screening 
for detection of breast cancer or other uses--(1) Identification. A 
nonelectrically powered or an AC-powered liquid crystal thermographic 
system intended for use as an adjunct to physical palpation or 
mammography in diagnostic screening for detection of breast cancer or 
other uses is a nonelectrically powered or an AC-powered device applied 
to the skin that displays the color patterns of heat sensitive 
cholesteric liquid crystals that respond to temperature variations of 
the surface of the body. This generic type of device may include patient 
and equipment supports, a means to ensure thermal contact between the 
patient's skin and the liquid crystals, component parts, and 
accessories.
    (2) Classification. Class I (general controls).
    (b) A nonelectrically powered or an AC-powered liquid crystal 
thermographic system intended for use alone in diagnostic screening for 
detection of breast cancer or other uses--(1) Identification. A 
nonelectrically powered or an AC-powered liquid crystal thermographic 
system intended for use as the sole diagnostic screening tool for 
detection of breast cancer or other uses is a nonelectrically powered or 
an AC-powered device applied to the skin that displays the color 
patterns of heat sensitive cholesteric liquid crystals that respond to 
temperature variations of the surface of the body. This generic type of 
device may include image display and recording equipment, patient and 
equipment supports, a means to ensure thermal contact between the 
patient's skin and the liquid crystals, 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

[[Page 437]]

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 48441, Nov. 20, 1990; 66 
FR 46953, Sept. 10, 2001]