美国医疗器械分类目录-第892部分放射学设备

标题 21--食品和药品
第一章--食品和药物管理局
卫生与公众服务
部 分章 h 分章 - 医疗器械

第892部分放射学设备

subpart b - diagnostic devices

   § 892.1000 - magnetic resonance diagnosticdevice.
   § 892.1100 - scintillation (gamma)camera.
   § 892.1110 - positron camera.
   § 892.1130 - nuclear whole body counter.
   § 892.1170 - bone densitometer.
   § 892.1180 - bone sonometer.
   § 892.1200 - emission computed tomographysystem.
   § 892.1220 - fluorescent scanner.
   § 892.1300 - nuclear rectilinearscanner.
   § 892.1310 - nuclear tomography system.
   § 892.1320 - nuclear uptake probe.
   § 892.1330 - nuclear whole body scanner.
   § 892.1350 - nuclear scanning bed.
   § 892.1360 - radionuclide dosecalibrator.
   § 892.1370 - nuclear anthropomorphicphantom.
   § 892.1380 - nuclear flood sourcephantom.
   § 892.1390 - radionuclide rebreathingsystem.
   § 892.1400 - nuclear sealed calibrationsource.
   § 892.1410 - nuclear electrocardiographsynchronizer.
   § 892.1420 - radionuclide test patternphantom.
   § 892.1540 - nonfetal ultrasonicmonitor.
   § 892.1550 - ultrasonic pulsed dopplerimaging system.
   § 892.1560 - ultrasonic pulsed echo imagingsystem.
   § 892.1570 - diagnostic ultrasonictransducer.
   § 892.1600 - angiographic x-ray system.
   § 892.1610 - diagnostic x-ray beam-limitingdevice.
   § 892.1620 - cine or spot fluorographicx-ray camera.
   § 892.1630 - electrostatic x-ray imagingsystem.
   § 892.1640 - radiographic film markingsystem.
   § 892.1650 - image-intensified fluoroscopicx-ray system.
   § 892.1660 - non-image-intensifiedfluoroscopic x-ray system.
   § 892.1670 - spot-film device.
   § 892.1680 - stationary x-ray system.
   § 892.1700 - diagnostic x-ray high voltagegenerator.
   § 892.1710 - mammographic x-ray system.
   § 892.1715 - full-field digital mammographysystem.
   § 892.1720 - mobile x-ray system.
   § 892.1730 - photofluorographic x-raysystem.
   § 892.1740 - tomographic x-ray system.
   § 892.1750 - computed tomography x-raysystem.
   § 892.1760 - diagnostic x-ray tube housingassembly.
   § 892.1770 - diagnostic x-ray tubemount.
   § 892.1820 - pneumoencephalographicchair.
   § 892.1830 - radiologic patient cradle.
   § 892.1840 - radiographic film.
   § 892.1850 - radiographic film cassette.
   § 892.1860 - radiographic film/cassettechanger.
   § 892.1870 - radiographic film/cassettechanger programmer.
   § 892.1880 - wall-mounted radiographiccassette holder.
   § 892.1890 - radiographic filmilluminator.
   § 892.1900 - automatic radiographic filmprocessor.
   § 892.1910 - radiographic grid.
   § 892.1920 - radiographic head holder.
   § 892.1940 - radiologic assuranceinstrument.
   § 892.1950 - radiographic anthropomorphicphantom.
   § 892.1960 - radiographic intensifyingscreen.
   § 892.1970 - radiographic ecg/respiratorsynchronizer.
   § 892.1980 - radiologic table.
   § 892.1990 - transilluminator for breastevaluation.
   § 892.2010 - medical image storagedevice.
   § 892.2020 - medical image communicationsdevice.
   § 892.2030 - medical image digitizer.
   § 892.2040 - medical image hardcopydevice.
   § 892.2050 - medical image management andprocessing system.
   § 892.2060 - radiological computer-assisteddiagnostic software for lesions suspicious of cancer.
   § 892.2070 - medical image analyzer.
   § 892.2080 - radiological computer aidedtriage and notification software.

subparts c-e [reserved]

subpart f - therapeutic devices
   § 892.5050 - medical charged-particleradiation therapy system.
   § 892.5300 - medical neutron radiationtherapy system.
   § 892.5650 - manual radionuclide applicatorsystem.
   § 892.5700 - remote controlled radionuclideapplicator system.
   § 892.5710 - radiation therapy beam-shapingblock.
   § 892.5720 - rectal balloon for prostateimmobilization.
   § 892.5725 - absorbable perirectalspacer.
   § 892.5730 - radionuclide brachytherapysource.
   § 892.5740 - radionuclide teletherapysource.
   § 892.5750 - radionuclide radiation therapysystem.
   § 892.5770 - powered radiation therapypatient support assembly.
   § 892.5780 - light beam patient positionindicator.
   § 892.5840 - radiation therapy simulationsystem.
   § 892.5900 - x-ray radiation therapysystem.
   § 892.5930 - therapeutic x-ray tube housingassembly.

subpart g - miscellaneous devices
   § 892.6500 - personnel protectiveshield.