Table 5. Radiation Oncology Device Listing and Licensure Date for All Categories .

Device name	Classification	Company	CAN issue date	USA issue date	Date difference: USA before CAN	Date difference: CAN before USA
Axxent Radiation Shield Rigid	Accessory	XOFT, INC., A SUBSIDIARY OF ICAD	20-Mar-12	20-Jul-11	244	n/a
Spaceoar System	Accessory	AUGMENIX	5-Feb-16	25-Jun-18	n/a	871
I-seed Model AgX100	Brachytherapy	THERAGENICS CORPORATION	7-Apr-11	3-Jan-11	94	n/a
Axxent Vaginal Applicator Set	Brachytherapy	XOFT, INC., A SUBSIDIARY OF ICAD	6-Feb-09	9-May-08	273	n/a
Radioactive Seed Localization Needle	Brachytherapy	ISOAID L.L.C.	19-Jan-16	5-Dec-14	410	n/a
Advantage I-125 Brachytherapy Seeds	Brachytherapy	ISOAID L.L.C.	4-Dec-03	7-Oct-01	788	n/a
Advantage Pd-103 Brachytherapy Seeds	Brachytherapy	ISOAID L.L.C.	4-Dec-03	8-Apr-04	n/a	126
Axxent Balloon Applicator Kit  AB2034	Brachytherapy	XOFT, INC., A SUBSIDIARY OF ICAD	6-Feb-09	16-Jul-09	n/a	160
Exactrac Patient Positioning System	Imaging & Monitoring Accessory	BRAINLAB AG	25-Jan-02	14-Jul-99	926	n/a
Catalyst	Imaging & Monitoring Accessory	C-RAD POSITIONING AB	17-Feb-15	27-Feb-12	1086	n/a
Sentinel, Sp-001	Imaging & Monitoring Accessory	C-RAD POSITIONING AB	30-Apr-14	30-Mar-09	1857	n/a
AlignRT	Imaging & Monitoring Accessory	VISION RT LIMITED	8-Jul-15	6-Jan-06	3470	n/a
Mridian Linac System	Linear Accelerator	VIEWRAY INCORPORATED	2-Aug-17	24-Feb-17	159	n/a
Oncor Expression Digital Linear Accelerator	Linear Accelerator	SIEMENS	28-Aug-06	15-Mar-06	166	n/a
Artiste Mv - Linear Accelerator	Linear Accelerator	SIEMENS	12-Aug-08	27-Dec-07	229	n/a
Halcyon Medical Linear Accelerator	Linear Accelerator	VARIAN MEDICAL SYSTEMS, INC	6-Jul-18	27-Jun-17	374	n/a
Tomotherapy Treatment System Tomohd	Linear Accelerator	ACCURAY	27-Nov-13	29-Aug-12	455	n/a
Radixact Treatment Delivery System	Linear Accelerator	ACCURAY	2-Oct-17	24-Jun-16	465	n/a
Novalis (Shaped Beam Surgery System)	Linear Accelerator	BRAINLAB AG	2-Dec-03	3-Nov-00	1124	n/a
Cyberknife Robotic Radiosurgery System - 1000 Mu/Minute Linear Accelerator	Linear Accelerator	ACCURAY	16-Aug-06	30-Oct-06	n/a	75
Brainscan Stereotactic Radiosurgery System	Linear Accelerator	BRAINLAB AG	8-Feb-00	13-Jul-00	n/a	156
Leksell Gamma Knife Perfexion	Linear Accelerator	ELEKTA INSTRUMENT AB	30-Aug-06	5-Mar-07	n/a	187
Truebeam	Linear Accelerator	VARIAN MEDICAL SYSTEMS, INC	2-Dec-10	18-Aug-11	n/a	259
Cyberknife M6 Series System	Linear Accelerator	ACCURAY	23-Oct-13	7-Jan-15	n/a	441
Cyberknife Vsi Robotic Radiosurgery System	Linear Accelerator	ACCURAY	18-Mar-11	26-Oct-12	n/a	588
Mevion S250 Proton Beam Radiation Therapy System	Proton Accelerator	MEVION MEDICAL SYSTEMS	9-Jan-15	4-Jun-12	949	n/a

Device name	Classification	Company	CAN issue date	USA issue date	Date difference: USA before CAN	Date difference: CAN before USA
Delta4 Phantom+	Quality Assurance	SCANDIDOS AB	18-Sep-15	19-Aug-15	30	n/a
Perfraction	Quality Assurance	SUN NUCLEAR CORPORATION	3-Nov-14	26-Sep-14	38	n/a
Portable Dosimeter TN-RD-90	Quality Assurance	BEST MEDICAL CANADA	25-Oct-10	28-Aug-09	423	n/a
Profiler 2	Quality Assurance	SUN NUCLEAR CORPORATION	7-Feb-08	22-Nov-06	442	n/a
3D Scanner	Quality Assurance	SUN NUCLEAR CORPORATION	29-Sep-10	1-Oct-10	n/a	2
IGM Integral Quality Monitor	Quality Assurance	IRT SYSTEMS GMBH	14-Sep-16	20-Oct-16	n/a	36
Mobius3d	Quality Assurance	MOBIUS MEDICAL SYSTEMS, LP	17-Jan-13	24-Jun-14	n/a	523
Srt-100 Superficial Radiation Therapy System	Superficial Radiotherapy	SENSUS HEALTHCARE	1-Nov-12	14-May-13	n/a	194
Integrity	Treatment Planning/Record & Verify Software	ELEKTA LIMITED	27-Jan-12	16-Dec-11	42	n/a
Aria Radiation Therapy Management	Treatment Planning/Record & Verify Software	VARIAN MEDICAL SYSTEMS, INC	21-May-14	4-Apr-14	47	n/a
Iplan! (Stereotactic Planning Software)	Treatment Planning/Record & Verify Software	BRAINLAB AG	8-Dec-04	22-Oct-04	47	n/a
Mobile Mim	Treatment Planning/Record & Verify Software	MIM SOFTWARE INC	24-Mar-11	4-Feb-11	48	n/a
Accuray Precision Treatment Planning System	Treatment Planning/Record & Verify Software	ACCURAY	30-Oct-17	8-Jun-17	144	n/a
iViewDose	Treatment Planning/Record & Verify Software	ELEKTA LIMITED	27-May-16	11-Dec-15	168	n/a
Eclipse Treatment Planning System V13.0	Treatment Planning/Record & Verify Software	VARIAN MEDICAL SYSTEMS, INC	4-Sep-14	7-Feb-14	209	n/a
Raystation 5	Treatment Planning/Record & Verify Software	RAYSEARCH LABORATORIES AB (PUBL)	14-Nov-16	8-Mar-16	251	n/a
Variseed 9.0	Treatment Planning/Record & Verify Software	VARIAN MEDICAL SYSTEMS, INC	1-Feb-16	8-May-15	269	n/a
OnQ rts Software	Treatment Planning/Record & Verify Software	ONCOLOGY SYSTEMS LIMITED	27-Sep-13	28-Dec-12	273	n/a
mobileMOSFET Wireless Dosimetry System	Treatment Planning/Record & Verify Software	BEST MEDICAL CANADA	13-Apr-05	25-Jun-04	292	n/a
Eclipse Treatment Planning System V15.5	Treatment Planning/Record & Verify Software	VARIAN MEDICAL SYSTEMS, INC	6-Jul-18	15-Aug-17	325	n/a
Eclipse Treatment Planning System V13.5	Treatment Planning/Record & Verify Software	VARIAN MEDICAL SYSTEMS, INC	28-Aug-15	7-Aug-14	386	n/a
Variseed 7.0	Treatment Planning/Record & Verify Software	VARIAN MEDICAL SYSTEMS, INC	31-Jan-03	12-Jul-01	568	n/a
Eclipse Treatment Planning System V6.5	Treatment Planning/Record & Verify Software	VARIAN MEDICAL SYSTEMS, INC	7-Jun-04	2-May-01	1132	n/a
Variseed 7.1	Treatment Planning/Record & Verify Software	VARIAN MEDICAL SYSTEMS, INC	11-Feb-04	21-May-04	n/a	100
Pinnacle 3 Radiation Therapy Planning System	Treatment Planning/Record & Verify Software	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC	28-Feb-00	14-Jun-13	n/a	4855