21 CFR 884.2982 - Liquid crystal thermographic system.

§ 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 is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.
[53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48441, Nov. 20, 1990; 66 FR 46953, Sept. 10, 2001]

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 884 after this date.

  • 2014-05-01; vol. 79 # 84 - Thursday, May 1, 2014
    1. 79 FR 24634 - Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed order.
      Submit either electronic or written comments on this proposed order by July 30, 2014. Please see section XIII for the proposed effective date of any final order that may publish based on this proposal.
      21 CFR Part 884