No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00812444024739 | GM1054 | BRACHYTHERAPY | NEU | Marker, Radiographic, Implantable | 2 | GOLD MARKER | |
2 | 00812444024418 | HSST13-239C | SUTURE | GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | HS SUTURE TAPE | |
3 | 00812444024364 | VG493 | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | PGA | |
4 | 00812444024371 | VG548 | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | PGA | |
5 | 00812444024357 | VG492 | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | PGA | |
6 | 00812444024340 | VG422 | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | PGA | |
7 | 00812444024050 | Q732C | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | MONO Q | |
8 | 00812444023985 | Q303 | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | MONO Q | |
9 | 00812444023527 | GM1033K | BRACHYTHERAPY | NEU | Marker, Radiographic, Implantable | 2 | GOLD MARKER | |
10 | 00812444023510 | GM0855 | BRACHYTHERAPY | NEU | Marker, Radiographic, Implantable | 2 | GOLD MARKER | |
11 | 00812444025996 | P8661 | SUTURE | GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | SURGIPOINT | |
12 | 00812444023312 | FN18-3 | BRACHYTHRAPY | KXK,IYE | Source, Brachytherapy, Radionuclide,Accelerator, Linear, Medical | 2 | FIDUCIAL NEEDLES | |
13 | 00812444023305 | FN17-3 | BRACHYTHERAPY | IYE | Accelerator, Linear, Medical | 2 | FIDUCIAL NEEDLES | |
14 | 00812444023299 | FN18-1 | BRACHYTHERAPY | KXK,IYE | Source, Brachytherapy, Radionuclide,Accelerator, Linear, Medical | 2 | FIDUCIAL NEEDLES | |
15 | 00812444023251 | FN-1720 | BRACHYTHERAPY | KXK | Source, Brachytherapy, Radionuclide | 2 | FIDUCIAL NEEDLES | |
16 | 00812444023282 | GM-1033 | BRACHYTHERAPY | NEU | Marker, Radiographic, Implantable | 2 | GOLD MARKER | |
17 | 00812444023275 | GM-123 | BRACHYTHERAPY | NEU | Marker, Radiographic, Implantable | 2 | GOLD MARKER | |
18 | 00812444023268 | FN-1720-2 | BRACHYTHERAPY | KXK | Source, Brachytherapy, Radionuclide | 2 | FIDUCIAL NEEDLES | |
19 | 00812444023244 | FN17-31 | BRACHYTHERAPY | KXK,IYE | Source, Brachytherapy, Radionuclide,Accelerator, Linear, Medical | 2 | FIDUCIAL NEEDLES | |
20 | 00812444023237 | FN17-53 | BRACHYTHERAPY | KXK,IYE | Source, Brachytherapy, Radionuclide,Accelerator, Linear, Medical | 2 | FIDUCIAL NEEDLES | |
21 | 00812444021325 | Q967 | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | MONO Q | |
22 | 00812444021295 | Q936 | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | MONO Q | |
23 | 00812444029291 | D497 | Suture | NEW | Suture, Surgical, Absorbable, Polydioxanone | 2 | PDM | |
24 | 00812444021271 | Q922 | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | MONO Q | |
25 | 00812444026092 | V310 | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | SURGIPOINT | |
26 | 00812444026085 | P8601 | SUTURE | GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | SURGIPOINT | |
27 | 00812444029116 | HS1013-MU | Suture | GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | SutUp | |
28 | 00812444026436 | V301 | SUTURE | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | SURGIPOINT | |
29 | 00812444028492 | P1011C | Suture | GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | KLOSURE | |
30 | 00812444028348 | HS129-MU | Suture | GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | SutUp | |
31 | 00812444028331 | HS211-MU | Suture | GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | SutUp | |
32 | 00812444027563 | 9604013121 | Suture | NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 2 | KLOSURE | |
33 | 00812444027525 | 9602019381 | Suture | NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 2 | KLOSURE | |
34 | 00812444027396 | Q495 | Suture | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | SURGIPOINT | |
35 | 00812444027310 | 1100-1812X | Brachytherapy | KXK | Source, Brachytherapy, Radionuclide | Applicator Needle | ||
36 | 00812444027143 | IBGN001 | Brachytherapy | KXK | Source, Brachytherapy, Radionuclide | 2 | Brachytherapy Guide Needle | |
37 | 00812444027075 | V302U | Suture | GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | SURGIPOINT | |
38 | 00812444027068 | 9625013381 | Suture | GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | KLOSURE | |
39 | 00812444027051 | 9604116381 | Suture | NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 2 | KLOSURE | |
40 | 00812444027044 | 9603119381 | SUTURE | NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 2 | KLOSURE | |
41 | 00812444027037 | 9605113381 | Suture | NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 2 | KLOSURE | |
42 | 00812444027020 | 9626013381 | Suture | GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | KLOSURE | |
43 | 00812444026757 | HS211 | Suture | GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | HS SUTURE TAPE | |
44 | 00812444026740 | HS210 | Suture | GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | HS SUTURE TAPE | |
45 | 00812444026733 | HS208 | Suture | GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | HS SUTURE TAPE | |
46 | 00812444026726 | HS209 | Suture | GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | HS SUTURE TAPE | |
47 | 00812444026719 | HS207 | Suture | GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | HS SUTURE TAPE | |
48 | 00812444026702 | HS206 | Suture | GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | HS SUTURE TAPE | |
49 | 00812444026641 | 9603019001 | SUTURE | NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 2 | KLOSURE | |
50 | 00812444026634 | 9604016001 | SUTURE | NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 2 | KLOSURE |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00868029000391 | 23820 | Head Coil (Receive Only) | VIEWRAY INCORPORATED | ||
2 | 00868029000360 | 14774 | Medium Torso Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
3 | 00868029000353 | 14775 | Head Neck Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
4 | 00868029000346 | 20000-01 | MRIdian Linac System | VIEWRAY INCORPORATED | ||
5 | 00868029000315 | 12981 | Medium Torso Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
6 | 00868029000308 | 11765 | Head Neck Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
7 | 00867520000206 | RadCalc® | RadCalc®#1 Trusted Dosimetric Verification Software.RadCalc Software.LifeLine So RadCalc®#1 Trusted Dosimetric Verification Software.RadCalc Software.LifeLine Software, Inc. | RadCalc® | LIFELINE SOFTWARE INC | |
8 | 00866562000267 | 91330 | 91330 | Standard Imaging LinacView Software is a stand alone software medical device use Standard Imaging LinacView Software is a stand alone software medical device used for logfile analysis of radiation therapy systems. | Standard Imaging LinacView Software | STANDARD IMAGING INC. |
9 | 00866562000243 | v1 | 91350 | Standard Imaging Adaptivo Software is a stand alone software medical device used Standard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems. | Standard Imaging Adaptivo | STANDARD IMAGING INC. |
10 | 00866562000236 | v5 | 91309 | Standard Imaging PIPSpro Software is a stand alone software medical device used Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems. | Standard Imaging PIPSpro Software | STANDARD IMAGING INC. |
11 | 00866562000229 | v3 | 91326 | Standard Imaging IMSure QA Software is a stand alone software medical device use Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems. | Standard Imaging IMSure QA Software | STANDARD IMAGING INC. |
12 | 00866562000205 | 92260 | 92260 | Standard Imaging DoseView 3D is a medical device intended for performing water p Standard Imaging DoseView 3D is a medical device intended for performing water phantom based commissioning and QA measurements on radiation therapy systems. | Standard Imaging DoseView 3D | STANDARD IMAGING INC. |
13 | 00863284000315 | 1.x | SciMoCa is a standalone software product that allows clinicians to perform quali SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes. | SciMoCa | RADIALOGICA LLC | |
14 | 00862246000301 | 206 | 206 | The CNMC Model 206 is a medical dosimeter or medical electrometer that is capabl The CNMC Model 206 is a medical dosimeter or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected. | 206 Electrometer | CNMC CO., INC. |
15 | 00861334000339 | 6.8.0 | DoseLab Pro | Dosimetry QA Software | DoseLab Pro | VARIAN MEDICAL SYSTEMS, INC. |
16 | 00861334000315 | 2.0.1 | Mobius3D | Secondary Check QA Software | Mobius3D | VARIAN MEDICAL SYSTEMS, INC. |
17 | 00861206000382 | 30x40 Wax Range Compensator | Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufa Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and designed by the customer for intensity modulation of external beam proton radiation therapy. Each Compensator is patient specific and for single use. | Proton Systems, LLC | PROTON SYSTEMS VIRGINIA LLC | |
18 | 00861206000375 | 30x40 Brass 360 Aperture | Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the custom Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is patient specific and for single use. | Proton Systems, LLC | PROTON SYSTEMS VIRGINIA LLC | |
19 | 00861206000368 | 25cm Wax Range Compensator | Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufa Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and designed by the customer for intensity modulation of external beam proton radiation therapy. Each Compensator is patient specific and for single use | Proton Systems, LLC | PROTON SYSTEMS VIRGINIA LLC | |
20 | 00861206000351 | 25cm Brass 360 Apertrure | Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the custom Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is patient specific and for single use. | Proton Systems, LLC | PROTON SYSTEMS VIRGINIA LLC | |
21 | 00861206000344 | 18cm Wax Range Compensator | Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufa Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and designed by the customer for intensity modulation of external beam proton radiation therapy. Each Compensator is patient specific and for single use. | Proton Systems, LLC | PROTON SYSTEMS VIRGINIA LLC | |
22 | 00861206000337 | 18cm Brass 360 Aperture | Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the custom Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is patient specific and for single use. | Proton Systems, LLC | PROTON SYSTEMS VIRGINIA LLC | |
23 | 00860321001410 | WP-3840 | WP-3840 | 1D Dosimetry Water Phantom | Water Phantoms with Depth Positioning Assembly | CNMC CO., INC. |
24 | 00860321001403 | WP-3040 / WP-3840 | WP-3040 | 1D Dosimetry Water Phantom. | Water Phantoms with Depth Positioning Assembly | CNMC CO., INC. |
25 | 00860183001535 | 300153 | The Zap-X MV Imager is designed for use with the Zap-X Radiosurgery System (“Zap The Zap-X MV Imager is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation. | Zap-X MV Imager | ZAP SURGICAL SYSTEMS, INC. | |
26 | 00860183001528 | 300152 | The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosu The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation. | Zap-X Treatment Planning Software | ZAP SURGICAL SYSTEMS, INC. | |
27 | 00860183001511 | 300151 | The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosu The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation. | Zap-X Treatment Delivery Software | ZAP SURGICAL SYSTEMS, INC. | |
28 | 00860183001504 | 300150 | The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system f The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation. | Zap-X Radiosurgery System | ZAP SURGICAL SYSTEMS, INC. | |
29 | 00860175002403 | MUCheck® | MUCheck® Independent Dose Calculation Software. MUCheck® Software. MUCheck® Soft MUCheck® Independent Dose Calculation Software. MUCheck® Software. MUCheck® Software Suite. Oncology Data Systems, Inc. | MUCheck® | ONCOLOGY DATA SYSTEMS INC | |
30 | 00860003983805 | RXM1000 | The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy syste The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable ofdelivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT),stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT(kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice widthchoices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileafcollimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. Itcan achieve a nominal dose rate of 850 cGy/min. | Reflexion Medical Radiotherapy System | REFLEXION MEDICAL, INC. | |
31 | 00860003399903 | microSTAR® ii Dosimetry System | 18000-000 | The LANDAUER microSTAR®ii dosimetry system includes a compact, lightweight and p The LANDAUER microSTAR®ii dosimetry system includes a compact, lightweight and portable dosimeter reader that relies on Optically Stimulated Luminescence (OSL) technology for secondary verification of radiation dose for patient therapy Quality Assurance (QA). | LANDAUER | LANDAUER, INC. |
32 | 00860001672749 | 1.2 | ChartCheck assists in quality assessment of radiotherapy treatment plans and on ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, imaging, and documentation data in a simple, web-based interface. | ChartCheck | RADFORMATION, INC | |
33 | 00860001672718 | 2.3 | EZFluence is intended to assist radiation treatment planning professionals in ge EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photo treatment fields. | EZFluence | RADFORMATION, INC | |
34 | 00860001672701 | 2.0 | ClearCheck is intended for quality assessment of radiotherapy treatment plans. | ClearCheck | RADFORMATION, INC | |
35 | 00860001523218 | PFL-02PV | PFL-02PV | Personalized PseudoPatient™ PV FL | Personalized PseudoPatient™ PV | RTSAFE, INC. |
36 | 00860001523201 | PIC-02PV | PIC-02PV | Personalized PseudoPatient™ PV IC | Personalized PseudoPatient™ PV | RTSAFE, INC. |
37 | 00859032007156 | v3.0 | Panther OIS | PROWESS, INC. | ||
38 | 00859032007095 | v2.31 | Panther OIS R&V | PROWESS, INC. | ||
39 | 00858164002367 | MOSAIQ | MOSAIQ | ELEKTA, INC. | ||
40 | 00858164002336 | MOSAIQ | MOSAIQ | ELEKTA, INC. | ||
41 | 00858164002282 | MOSAIQ | MOSAIQ | ELEKTA, INC. | ||
42 | 00858164002251 | MOSAIQ | MOSAIQ | ELEKTA, INC. | ||
43 | 00858164002237 | MOSAIQ | MOSAIQ | ELEKTA, INC. | ||
44 | 00858164002220 | MOSAIQ | MOSAIQ | ELEKTA, INC. | ||
45 | 00858164002091 | MOSAIQ | MOSAIQ | ELEKTA, INC. | ||
46 | 00858086006764 | 89004004 | Varian Collimator Accessories Lower port film graticule for MLC | VARIAN MEDICAL SYSTEMS, INC. | ||
47 | 00858086006757 | 89003005 | Varian Collimator Accessories Upper port film graticule for MLC | VARIAN MEDICAL SYSTEMS, INC. | ||
48 | 00858086006740 | 10004249721 | Varian Collimator Accessories Lead wedge set upper (JITKIT) | VARIAN MEDICAL SYSTEMS, INC. | ||
49 | 00858086006733 | 10004249720 | Varian Collimator Accessories Lead wedge set lower (JITKIT) | VARIAN MEDICAL SYSTEMS, INC. | ||
50 | 00858086006726 | 10004249719 | Varian Collimator Accessories 30 CM wedge set upper (JITKIT) | VARIAN MEDICAL SYSTEMS, INC. |