Radiology

Page 1 of 1

Code	Device name	Class	21 CFR	510(k) (3y)
EAJ	Apron, Leaded	Class 1	21 CFR 892.6500	6
EAK	Screen, Leaded, Operator Radiation Protector	Class 1	21 CFR 892.6500	7
EAM	Screen, Intensifying, Radiographic	Class 1	21 CFR 892.1960	35
EGT	Controller, Temperature, Radiographic	Class 2	21 CFR 892.1900
EGW	Dryer, Film, Radiographic	Class 2	21 CFR 892.1900	2
EGY	Processor, Radiographic-Film, Automatic, Dental	Class 2	21 CFR 892.1900	9
HBK	Chair, Pneumoencephalographic	Class 2	21 CFR 892.1820
ITX	Transducer, Ultrasonic, Diagnostic	Class 2	21 CFR 892.1570	414
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Class 1	21 CFR 892.1760	40
ITZ	Assembly, Tube Housing, X-Ray, Therapeutic	Class 2	21 CFR 892.5930
IWA	Source, Wire, Iridium, Radioactive	Class 2	21 CFR 892.5730	8
IWB	System, Radiation Therapy, Radionuclide	Class 2	21 CFR 892.5750	48
IWD	Device, Beam Limiting, Teletherapy, Radionuclide	Class 2	21 CFR 892.5750	1
IWE	Monitor, Patient Position, Light-Beam	Class 1	21 CFR 892.5780	28
IWF	Needle, Isotope, Gold, Titanium, Platinum	Class 2	21 CFR 892.5730
IWG	Seed, Isotope, Gold, Titanium, Platinum	Class 2	21 CFR 892.5730	3
IWH	Source, Teletherapy, Radionuclide	Class 1	21 CFR 892.5740
IWI	Source, Isotope, Sealed, Gold, Titanium, Platinum	Class 2	21 CFR 892.5730	6
IWJ	System, Applicator, Radionuclide, Manual	Class 1	21 CFR 892.5650	36
IWK	Cyclotron, Medical	Class 2	21 CFR 892.5050
IWL	System, Radiation Therapy, Neutron, Medical	Class 2	21 CFR 892.5300	4
IWM	Synchrotron, Medical	Class 2	21 CFR 892.5050	1
IWN	Cassette, Measurement, Ardran-Crooks	Class 1	21 CFR 892.1940	1
IWO	Apron, Protective	Class 1	21 CFR 892.6500	1
IWP	Radiographic Protective Glove	Class 1	21 CFR 892.6500	5
IWQ	Curtain, Protective, Radiographic	Class 1	21 CFR 892.6500	3
IWR	Holder, Syringe, Lead	Class 1	21 CFR 892.6500	4
IWS	Shield, Eye, Radiological	Class 1	21 CFR 892.6500	6
IWT	Shield, Gonadal	Class 1	21 CFR 892.6500	2
IWW	Shield, Vial	Class 1	21 CFR 892.6500	1
IWX	Barrier, Control Panel, X-Ray, Movable	Class 1	21 CFR 892.6500	3
IWY	Holder, Head, Radiographic	Class 1	21 CFR 892.1920	10
IWZ	Film, Radiographic	Class 1	21 CFR 892.1840	34
IXA	Cassette, Radiographic Film	Class 2	21 CFR 892.1850	51
IXC	Illuminator, Radiographic-Film	Class 1	21 CFR 892.1890	18
IXD	Source, Calibration, Sealed, Nuclear	Class 1	21 CFR 892.1400	2
IXF	Test-Pattern, Radiographic	Class 1	21 CFR 892.1940	5
IXG	Phantom, Anthropomorphic, Radiographic	Class 1	21 CFR 892.1950	4
IXH	Camera, Focal Spot, Radiographic	Class 1	21 CFR 892.1940	2
IXI	Block, Beam-Shaping, Radiation Therapy	Class 2	21 CFR 892.5710	51
IXJ	Grid, Radiographic	Class 1	21 CFR 892.1910	15
IXK	System, Imaging, X-Ray, Electrostatic	Class 2	21 CFR 892.1630	14
IXL	Device, Spot-Film	Class 2	21 CFR 892.1670	13
IXO	Synchronizer, Ecg / Respirator, Radiographic	Class 1	21 CFR 892.1970	4
IXQ	Table, Radiographic, Stationary Top	Class 2	21 CFR 892.1980	27
IXR	Table, Radiographic, Tilting	Class 2	21 CFR 892.1980	77
IXW	Processor, Radiographic-Film, Automatic	Class 2	21 CFR 892.1900	83
IXX	Processor, Cine Film	Class 2	21 CFR 892.1900	6
IXY	Holder, Radiographic Cassette, Wall-Mounted	Class 1	21 CFR 892.1880	21
IYB	Tube Mount, X-Ray, Diagnostic	Class 1	21 CFR 892.1770	40
IYC	Generator, Orthovoltage, Therapeutic X-Ray	Class 2	21 CFR 892.5900
IYD	Generator, Low Voltage, Therapeutic X-Ray	Class 2	21 CFR 892.5900	1
IYE	Accelerator, Linear, Medical	Class 2	21 CFR 892.5050	736
IYG	Betatron, Medical	Class 2	21 CFR 892.5050
IYH	Generator, Dermatological (Grenz Ray), Therapeutic X-Ray	Class 2	21 CFR 892.5900	1
IYI	Collimator, Orthovoltage, Therapeutic X-Ray	Class 2	21 CFR 892.5900	2
IYJ	Collimator, Low Voltage, Therapeutic X-Ray	Class 2	21 CFR 892.5900
IYK	Collimator, High Voltage, Therapeutic X-Ray	Class 2	21 CFR 892.5900
IYL	Collimator, Dermatological, Therapeutic X-Ray	Class 2	21 CFR 892.5900	1
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Class 2	21 CFR 892.1550	1182
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Class 2	21 CFR 892.1560	894
IYP	Phantom, Anthropomorphic, Nuclear	Class 1	21 CFR 892.1370	3
IYQ	Phantom, Flood Source, Nuclear	Class 1	21 CFR 892.1380
IYT	System, Rebreathing, Radionuclide	Class 2	21 CFR 892.1390	49
IYW	Scanner, Rectilinear, Nuclear	Class 1	21 CFR 892.1300	4
IYX	Camera, Scintillation (Gamma)	Class 1	21 CFR 892.1100	130
IYY	Synchronizer, Electrocardiograph, Nuclear	Class 1	21 CFR 892.1410	3
IYZ	Bed, Scanning, Nuclear	Class 1	21 CFR 892.1350	12
IZC	Camera, Positron	Class 1	21 CFR 892.1110
IZD	Probe, Uptake, Nuclear	Class 1	21 CFR 892.1320	30
IZF	System, X-Ray, Tomographic	Class 2	21 CFR 892.1740	42
IZG	System, X-Ray, Photofluorographic	Class 2	21 CFR 892.1730	7
IZH	System, X-Ray, Mammographic	Class 2	21 CFR 892.1710	176
IZI	System, X-Ray, Angiographic	Class 2	21 CFR 892.1600	199
IZJ	Camera, X-Ray, Fluorographic, Cine Or Spot	Class 2	21 CFR 892.1620	12
IZL	System, X-Ray, Mobile	Class 2	21 CFR 892.1720	237
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Class 1	21 CFR 892.1700	163
IZP	Programmer, Changer, Film/Cassette, Radiographic	Class 2	21 CFR 892.1870	10
IZS	Aperture, Radiographic	Class 2	21 CFR 892.1610	1
IZT	Cone, Radiographic	Class 2	21 CFR 892.1610	1
IZW	Collimator, Automatic, Radiographic	Class 2	21 CFR 892.1610	23
IZX	Collimator, Manual, Radiographic	Class 2	21 CFR 892.1610	17
IZZ	Table, Radiographic, Non-Tilting, Powered	Class 2	21 CFR 892.1980	29
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Class 2	21 CFR 892.1650	300
JAB	System, X-Ray, Fluoroscopic, Non-Image-Intensified	Class 2	21 CFR 892.1660	2
JAC	System, X-Ray, Film Marking, Radiographic	Class 1	21 CFR 892.1640	18
JAD	System, Therapeutic, X-Ray	Class 2	21 CFR 892.5900	53
JAE	Microtron, Medical	Class 2	21 CFR 892.5050
JAF	Monitor, Ultrasonic, Nonfetal	Class 2	21 CFR 892.1540	38
JAG	Illuminator, Radiographic-Film, Explosion-Proof	Class 1	21 CFR 892.1890
JAI	Couch, Radiation Therapy, Powered	Class 2	21 CFR 892.5770	32
JAK	System, X-Ray, Tomography, Computed	Class 2	21 CFR 892.1750	822
JAM	Scanner, Whole Body, Nuclear	Class 1	21 CFR 892.1330	3
JAN	Counter, Whole Body, Nuclear	Class 1	21 CFR 892.1130
JAO	Scanner, Fluorescent	Class 2	21 CFR 892.1220	2
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Class 2	21 CFR 892.5700	208
JAR	Phantom, Test-Pattern, Radionuclide	Class 1	21 CFR 892.1420
JWM	System, Tomographic, Nuclear	Class 2	21 CFR 892.1310	17
KGI	Densitometer, Bone	Class 2	21 CFR 892.1170	147
KPQ	System, Simulation, Radiation Therapy	Class 2	21 CFR 892.5840	70
KPR	System, X-Ray, Stationary	Class 2	21 CFR 892.1680	357
KPS	System, Tomography, Computed, Emission	Class 2	21 CFR 892.1200	472
KPT	Calibrator, Dose, Radionuclide	Class 2	21 CFR 892.1360	32
KPW	Device, Beam Limiting, X-Ray, Diagnostic	Class 2	21 CFR 892.1610	16
KPX	Changer, Radiographic Film/Cassette	Class 2	21 CFR 892.1860	26
KPY	Shield, Protective, Personnel	Class 1	21 CFR 892.6500	25
KPZ	Generator, High Voltage, X-Ray, Therapeutic	Class 2	21 CFR 892.5900	3
KQA	Device, Beam Limiting, X-Ray, Therapeutic	Class 2	21 CFR 892.5900	4
KXH	Cradle, Patient, Radiologic	Class 1	21 CFR 892.1830	9
KXJ	Table, Radiologic	Class 2	21 CFR 892.1980	31
KXK	Source, Brachytherapy, Radionuclide	Class 2	21 CFR 892.5730	151
LEK	Transilluminator (Diaphanoscope)	Class 3	21 CFR 892.1990
LHN	System, Radiation Therapy, Charged-Particle, Medical	Class 2	21 CFR 892.5050	92
LHO	Instrument, Quality-Assurance, Radiologic	Class 1	21 CFR 892.1940	8
LLZ	System, Image Processing, Radiological	Class 2	21 CFR 892.2050	2286
LMA	Digitizer, Image, Radiological	Class 2	21 CFR 892.2030	61
LMB	Device, Digital Image Storage, Radiological	Class 1	21 CFR 892.2010	55
LMC	Camera, Multi Format, Radiological	Class 2	21 CFR 892.2040	121
LMD	System, Digital Image Communications, Radiological	Class 1	21 CFR 892.2020	142
LNH	System, Nuclear Magnetic Resonance Imaging	Class 2	21 CFR 892.1000	1104
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Class 2	21 CFR 892.1000	10
LQA	Media, Reusable Image	Class 1	21 CFR 892.1840	1
LWI	Ultrasound, Sinus	Class 2	21 CFR 892.1560	4
MOS	Coil, Magnetic Resonance, Specialty	Class 2	21 CFR 892.1000	490
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Class 2	21 CFR 892.1680	424
MUA	Bone Sonometer	Class 2	21 CFR 892.1180	9
MUE	Full Field Digital, System, X-Ray, Mammographic	Class 2	21 CFR 892.1715	55
MUI	Media, Coupling, Ultrasound	Class 2	21 CFR 892.1570	34
MUJ	System, Planning, Radiation Therapy Treatment	Class 2	21 CFR 892.5050	257
MWP	Cabinet, X-Ray System	Class 2	21 CFR 892.1680	27
MWW	Accessory - Film Dosimetry System	Class 2	21 CFR 892.5050
MYN	Analyzer, Medical Image	Class 2	21 CFR 892.2070	39
NCS	System, Imaging, Holography, Acoustic	Class 2	21 CFR 892.1550	3
NFF	Device, Storage, Images, Ophthalmic	Class 1	21 CFR 892.2010	1
NFG	Device, Communications, Images, Ophthalmic	Class 1	21 CFR 892.2020
NFH	Digitizer, Images, Ophthalmic	Class 2	21 CFR 892.2030
NFI	Device, Hardcopy, Images, Ophthalmic	Class 2	21 CFR 892.2040
NFJ	System, Image Management, Ophthalmic	Class 2	21 CFR 892.2050	53
NMP	Needle, Isotope, Reprocessed	Class 2	21 CFR 892.5730
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Class 2	21 CFR 892.1560	46
NWE	Colon Computed Tomography System, Computer Aided Detection	Class 2	21 CFR 892.2050	4
NZT	Dosimeter, Ionizing Radiation, Implanted	Class 2	21 CFR 892.5050	7
OAS	X-Ray, Tomography, Computed, Dental	Class 2	21 CFR 892.1750	135
OEB	Lung Computed Tomography System, Computer-Aided Detection	Class 2	21 CFR 892.2050	20
OII	Arthrogram Tray	Class 2	21 CFR 892.1650
OIJ	Biopsy Needle Guide Kit	Class 2	21 CFR 892.1560
OIK	Radiology Dental Tray	Class 2	21 CFR 892.1650
OIL	Discography Kit	Class 2	21 CFR 892.1730
OIM	Mri Disposable Kit	Class 2	21 CFR 892.1000
OIN	Prostate Seeding Kit	Class 2	21 CFR 892.5730
OIO	Radiographic Contrast Tray	Class 2	21 CFR 892.1680
OIP	Radiology-Diagnostic Kit	Class 2	21 CFR 892.1680
OMJ	Chest X-Ray Computer Aided Detection	Class 2	21 CFR 892.2050	1
ONL	Conformal Brachytherapy Source	Class 2	21 CFR 892.5730	1
OQQ	Diagnostic Ultrasonic Transducer, Robotic	Class 2	21 CFR 892.1570	1
OUJ	High Level Disinfection Reprocessing Instrument For Ultrasonic Transdu	Class 2	21 CFR 892.1570	4
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear	Class 2	21 CFR 892.1200	15
OVB	Hydrogel Spacer	Class 2	21 CFR 892.5725	7
OWB	Interventional Fluoroscopic X-Ray System	Class 2	21 CFR 892.1650	325
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Class 2	21 CFR 892.1650	82
PCS	Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox	Class 2	21 CFR 892.1001	3
PCT	Prostate Immobilizer Rectal Balloon	Class 2	21 CFR 892.5720	5
PDK	Cream For X-Ray Attenuation	Class 2	21 CFR 892.6510	2
PGY	Display, Diagnostic Radiology	Class 2	21 CFR 892.2050	135
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cance	Class 2	21 CFR 892.2060	23
POY	Post Breast Biopsy Hemostatic Breast Compression Device	Class 2	21 CFR 892.1710	1
PSV	Ultrasound Bronchoscope	Class 2	21 CFR 892.1550	4
PSW	High Level Disinfection Reprocessing Instrument For Ultrasonic Transdu	Class 2	21 CFR 892.1570	7
PZO	Software For Visualization Of Vascular Anatomy And Intravascular Devic	Class 2	21 CFR 892.2050	10
QAS	Radiological Computer-Assisted Triage And Notification Software	Class 2	21 CFR 892.2080	87
QBS	Radiological Computer Assisted Detection/Diagnosis Software For Fractu	Class 2	21 CFR 892.2090	11
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesion	Class 2	21 CFR 892.2090	39
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Class 2	21 CFR 892.2080	41
QHA	X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software	Class 2	21 CFR 892.1600	7
QHX	Fluoroscopic X-Ray Image Intensifier	Class 1	21 CFR 892.1960
QHY	Solid State Fluoroscopic X-Ray Imager	Class 2	21 CFR 892.1650
QIH	Automated Radiological Image Processing Software	Class 2	21 CFR 892.2050	325
QJG	Device System, Imaging, Tympanic Membrane And Middle Ear	Class 2	21 CFR 892.1560	2
QJU	Image Acquisition And/Or Optimization Guided By Artificial Intelligenc	Class 2	21 CFR 892.2100	9
QKB	Radiological Image Processing Software For Radiation Therapy	Class 2	21 CFR 892.2050	49
QQE	Image Management Software For Planning Of Otologic And Neurotologic Pr	Class 2	21 CFR 892.2050	3
QRN	Radiation Therapy Marking Device	Class 2	21 CFR 892.5785	2
QTZ	Radiological Image Processing Software For Ablation Therapy Planning A	Class 2	21 CFR 892.2050	9
QUV	Phase-Changing Fiducial Marker For Radiation Therapy	Class 2	21 CFR 892.5727	1
QVA	Fludeoxyglucose F18-Guided Radiation Therapy System	Class 2	21 CFR 892.5060	2
QVD	Radiological Machine Learning Based Quantitative Imaging Software With	Class 2	21 CFR 892.2055	1
QWO	Radiology Software For Referral Of Findings Related To Fibrotic Lung D	Class 2	21 CFR 892.2085	4
QXL	Cabinet, Emission Computed Tomography System	Class 2	21 CFR 892.1200	1
QXR	Vaginal Hydrogel Packing System	Class 2	21 CFR 892.5735	1
QZL	Post-Ablation Tissue Response Prediction Software	Class 2	21 CFR 892.2052	2
RCC	C-Arm Fluoroscopic X-Ray System	Class 2	21 CFR 892.1650
RGC	X-Ray Field Indicator Light (Laser)	Class 1	21 CFR 892.5780
SAO	Radiology Software For Opportunistic Evaluation Of Low Bone Mineral De	Class 2	21 CFR 892.1171	3
SEZ	Radiological Software Device To Predict Future Breast Cancer Risk	Class 2	21 CFR 892.8500	1
SFV	X-Ray, Computed Tomography, Cone-Beam	Class 2	21 CFR 892.1750	1
SGH	Ultrasound Imaging For Vascular Access For Hemodialysis	Class 2	21 CFR 892.1560	1
SGJ	Ultrasound Imaging System For Acquiring Images At Home By Lay Users	Class 2	21 CFR 892.1590	1
SHE	Radiological Software System For Delivery Date Prediction	Class 2	21 CFR 892.8200	1
SHN	Calibration Software For Radiology Displays	Class 1	21 CFR 892.1940	1