No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00841439113929 | MTIL6057 | MTIL6057 | 41.5cm, non-conductive | IYE | Accelerator, linear, medical | 2 | Prodigy™ 2 Lok-Bar™ |
2 | 00841439113561 | BPL026 | BPL026 | BPL ONE Respiratory Belt | IYE,LNH | Accelerator, linear, medical,System, nuclear magnetic resonance imaging | 2 | BPL ONE Respiratory Belt |
3 | 00841439114049 | PRO450 | PRO450 | Pediatric Cushion Guide | IYE | Accelerator, linear, medical | 2 | Pediatric Cushion Guide |
4 | 00841439113912 | MTIL6056 | MTIL6056 | (41.5cm) | IXQ | Table, radiographic, stationary top | 2 | Prodigy™ 2 Lok-Bar™ |
5 | 00841439113738 | MTULB003 | MTULB003 | Non-conductive | IYE | Accelerator, linear, medical | 2 | Elekta Unity Lok-Bar™ |
6 | 00841439113424 | MTVR1000 | MTVR1000 | 50cm, Flat | IYE | Accelerator, linear, medical | 2 | Lok-Bar™ |
7 | 00841439113219 | MTULB001 | MTULB001 | Non-conductive | IYE | Accelerator, linear, medical | 2 | Elekta Unity Lok-Bar™ |
8 | 00841439113158 | PRO320 | PRO320 | ProForm™ MR Overlay | LNH | System, nuclear magnetic resonance imaging | 2 | ProForm™ MR Overlay |
9 | 00841439113059 | PRO340 | PRO340 | Registration Film | IYE | Accelerator, linear, medical | 2 | Registration Film |
10 | 00841439112540 | CHS42 | CHS42 | Size F headrest (23.6 x 9.5 x 7.6cm) | IYE | Accelerator, linear, medical | 2 | Head Support |
11 | 00841439112533 | CHS41 | CHS41 | Size C headrest (22.3 x 9.5 x 6.1cm) | IYE | Accelerator, linear, medical | 2 | Head Support |
12 | 00841439112526 | CHS40 | CHS40 | Size B headrest (23.6 x 9.5 x 4.9cm) | IYE | Accelerator, linear, medical | 2 | Head Support |
13 | 00841439111703 | MT6XSM1.7.4 | MT6XSM1.7.4 | Version 1.7.4 | JAI | Couch, radiation therapy, powered | 2 | Proutra™ |
14 | 00841439110874 | BPL010 | BPL010 | For use with evo couchtop (2) | IXQ | Table, radiographic, stationary top | 2 | Body Pro-Lok ONE™ evo Adapter |
15 | 00841439111376 | MT6XSM1.7.3 | MT6XSM1.7.3 | Version 1.7.3 | JAI | Couch, radiation therapy, powered | 2 | Proutra™ |
16 | 00841439111345 | MTRH1500EX | MTRH1500EX | 230V | KPY | Shield, protective, personnel | 1 | Waterbath |
17 | 00841439111338 | MTRH1500 | MTRH1500 | 120V | KPY | Shield, protective, personnel | 1 | Waterbath |
18 | 00841439111055 | 107102 | 107102 | 5 degree wedge | IYE | Accelerator, linear, medical | 2 | Wedge |
19 | 00841439111048 | 107101 | 107101 | 2.5 degree wedge | IYE | Accelerator, linear, medical | 2 | Wedge |
20 | 00841439110799 | MTIL666010 | MTIL666010 | Latch Mount Subassembly | IXQ | Table, radiographic, stationary top | 2 | Universal Couchtop Extension Latch Mount Subassembly |
21 | 00841439109625 | MTNW887712 | MTNW887712 | Sterile placement needles (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tiss Sterile placement needles (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker coupled with 17mm spacer and (1.0 x 3mm) soft tissue gold marker [2] | IYE | Accelerator, linear, medical | 2 | Coupled™ Fiducial Marker Kit |
22 | 00841439109618 | MTNW887711 | MTNW887711 | Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissu Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker couple with 17mm spacer and (1.0 x 3mm) soft tissue gold marker (blue styl-loc) Sterile placement needle (17GA ETW x 20cm) with bone wax and (1.2 x 3mm) soft tissue gold marker (white styl-loc) | IYE | Accelerator, linear, medical | 2 | Coupled™ Fiducial Marker Kit |
23 | 00841439109601 | MTNW887710 | MTNW887710 | Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissu Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker coupled with 17mm spacer and (1.0 x 3mm) soft tissue gold marker | IYE | Accelerator, linear, medical | 2 | Coupled™ Fiducial Marker Kit |
24 | 00841439109595 | MTNW887709 | MTNW887709 | Sterile placement needles (18GA ETW x 20cm) with bone wax, (0.8 x 3mm) soft tiss Sterile placement needles (18GA ETW x 20cm) with bone wax, (0.8 x 3mm) soft tissue gold marker coupled with 17mm spacer and (0.8 x 3mm) soft tissue gold marker [2] | IYE | Accelerator, linear, medical | 2 | Coupled™ Fiducial Marker Kit |
25 | 00841439108932 | MTZXTZ44069CS | MTZXTZ44069CS | Reusable non-sterile solid couchtop panel for use with Siemens ZXT or Z4 systems | KXJ | Table, radiologic | 2 | Couchtop Panel |
26 | 00841439108925 | MTZXTZ44069CF | MTZXTZ44069CF | Reusable non-sterile grid couchtop panel for use with Siemens ZXT or Z4 systems | KXJ | Table, radiologic | 2 | Couchtop Panel |
27 | 00841439108031 | MTTWSS | MTTWSS | Reusable non-sterile tilting wrist support | IYE | Accelerator, linear, medical | 2 | Wrist Support |
28 | 00841439108024 | MTTWS2S | MTTWS2S | Wrist Support - Tilting | IYE | Accelerator, linear, medical | 2 | Wrist Support |
29 | 00841439107614 | MTSBRT410 | MTSBRT410 | (53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(2), Type 2 Bri (53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(2), Type 2 Bridge(2), and Type 3 Bridge(1) | LNH,IYE | System, nuclear magnetic resonance imaging,Accelerator, linear, medical | 2 | Body Pro-Lok™ System Lite |
30 | 00841439107287 | MTSBRT0051 | MTSBRT0051 | Patient Hand Grip - Left | LNH,IXQ,IYE | System, nuclear magnetic resonance imaging,Table, radiographic, stationary top,A System, nuclear magnetic resonance imaging,Table, radiographic, stationary top,Accelerator, linear, medical | 2 | Patient Hand Grip |
31 | 00841439107591 | MTSBRT264 | MTSBRT264 | MR T-Pin lok-bar | LNH,IYE | System, nuclear magnetic resonance imaging,Accelerator, linear, medical | 2 | Lok-Bar™ |
32 | 00841439107492 | MTSBRT055 | MTSBRT055 | Lok-Bar™ (2-Pin) | IXQ,LNH,IYE | Table, radiographic, stationary top,System, nuclear magnetic resonance imaging,A Table, radiographic, stationary top,System, nuclear magnetic resonance imaging,Accelerator, linear, medical | 2 | Lok-Bar™ |
33 | 00841439107485 | MTSBRT054 | MTSBRT054 | Lok-Bar™ (3-Pin) | IYE,IXQ,LNH | Accelerator, linear, medical,Table, radiographic, stationary top,System, nuclear Accelerator, linear, medical,Table, radiographic, stationary top,System, nuclear magnetic resonance imaging | 2 | Lok-Bar™ |
34 | 00841439107331 | MTSBRT014 | MTSBRT014 | Transfer Guide | IXQ | Table, radiographic, stationary top | 2 | Transfer Guide |
35 | 00841439107232 | MTSBRT001L | MTSBRT001L | (53cm x 210.8cm) overlay with T-Pin Lok-Bar™s(4), Type1B Bridge (2), Type 2 Brid (53cm x 210.8cm) overlay with T-Pin Lok-Bar™s(4), Type1B Bridge (2), Type 2 Bridge (2), Type 3 Bridge (1) and 8" Clam-Lok™ Cushion(1) | IXQ,IYE | Table, radiographic, stationary top,Accelerator, linear, medical | 2 | Body Pro-Lok™ System Lite |
36 | 00841439106730 | MTM3402 | MTM3402 | Reusable Panorama 50cm overlay with Prodigy Lok-Bar, supports (4), risers (4), a Reusable Panorama 50cm overlay with Prodigy Lok-Bar, supports (4), risers (4), adhesive, abrasive paper, button location fixtures | IYE | Accelerator, linear, medical | 2 | IPPS Overlay |
37 | 00841439106389 | MTIL662502 | MTIL662502 | For use with Universal Couchtop™ | IXQ,IYE | Table, radiographic, stationary top,Accelerator, linear, medical | 2 | Patient Hand Grip |
38 | 00841439106372 | MTIL662501 | MTIL662501 | For use with Universal Couchtop™ | IXQ,IYE | Table, radiographic, stationary top,Accelerator, linear, medical | 2 | Patient Hand Grip |
39 | 00841439106211 | MTIL6561 | MTIL6561 | Reusable non-sterile Toshiba Aquilion One CT cradle top | IXQ | Table, radiographic, stationary top | 2 | IPPS Overlay |
40 | 00841439106204 | MTIL6560 | MTIL6560 | Reusable non-sterile Toshiba Aquilion CT cradle top | IXQ | Table, radiographic, stationary top | 2 | IPPS Overlay |
41 | 00841439106082 | MTIL6460 | MTIL6460 | Reusable non-sterile Philips Brilliance CT cradle top | IXQ | Table, radiographic, stationary top | 2 | IPPS Overlay |
42 | 00841439106013 | MTIL6363 | MTIL6363 | Reusable non-sterile GE VCT Global 2000 CT cradle top | IXQ | Table, radiographic, stationary top | 2 | IPPS Overlay |
43 | 00841439106006 | MTIL6362 | MTIL6362 | Reusable non-sterile GE VCT Global 1700 CT cradle top | IXQ | Table, radiographic, stationary top | 2 | IPPS Overlay |
44 | 00841439105993 | MTIL6361 | MTIL6361 | Reusable non-sterile GE Discovery STCT cradle top | IXQ | Table, radiographic, stationary top | 2 | IPPS Overlay |
45 | 00841439105986 | MTIL6360 | MTIL6360 | Reusable non-sterile GE Hi-Speed CT cradle top | IXQ | Table, radiographic, stationary top | 2 | IPPS Overlay |
46 | 00841439105849 | MTIL630311 | MTIL630311 | For use with GE VCT Global 2000 CT | IXQ | Table, radiographic, stationary top | 2 | Lateral Stabilizer |
47 | 00841439105818 | MTIL630211 | MTIL630211 | For use with GE VCT Global 1700 CT | IXQ | Table, radiographic, stationary top | 2 | Lateral Stabilizer |
48 | 00841439105788 | MTIL630111 | MTIL630111 | Reusable non-sterile lateral stabilizer for use with GE Discovery ST CT | IXQ | Table, radiographic, stationary top | 2 | Lateral Stabilizer |
49 | 00841439105740 | MTIL630011 | MTIL630011 | For use with GE Hi-Speed CT | IXQ | Table, radiographic, stationary top | 2 | Lateral Stabilizer |
50 | 00841439105672 | MTIL6161 | MTIL6161 | Reusable non-sterile Varian Exact Couchtop with Lok-Bar and rectangular extension | IXQ | Table, radiographic, stationary top | 2 | IPPS Overlay |
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 | 00868029000360 | 14774 | Medium Torso Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
4 | 00868029000353 | 14775 | Head Neck Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
5 | 00868029000353 | 14775 | Head Neck Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
6 | 00868029000346 | 20000-01 | MRIdian Linac System | VIEWRAY INCORPORATED | ||
7 | 00868029000346 | 20000-01 | MRIdian Linac System | VIEWRAY INCORPORATED | ||
8 | 00868029000315 | 12981 | Medium Torso Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
9 | 00868029000315 | 12981 | Medium Torso Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
10 | 00868029000308 | 11765 | Head Neck Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
11 | 00868029000308 | 11765 | Head Neck Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
12 | 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 | |
13 | 00867170000106 | VS5060 | Vascular Flow Analysis System | NOVA | VASSOL, INC. | |
14 | 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. |
15 | 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. |
16 | 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. |
17 | 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. |
18 | 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. |
19 | 00866463000410 | 1.1 | 200003 | STAGE works as a comprehensive brain imaging post-processing solution. The STAGE STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available. | STAGE | SPINTECH, INC. |
20 | 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 | |
21 | 00862694000304 | TMS-MRI-3500wb-02 | PICA Whole-body MRI System | TIME MEDICAL SYSTEMS | ||
22 | 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. |
23 | 00861334000339 | 6.8.0 | DoseLab Pro | Dosimetry QA Software | DoseLab Pro | VARIAN MEDICAL SYSTEMS, INC. |
24 | 00861334000315 | 2.0.1 | Mobius3D | Secondary Check QA Software | Mobius3D | VARIAN MEDICAL SYSTEMS, INC. |
25 | 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 | |
26 | 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 | |
27 | 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 | |
28 | 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 | |
29 | 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 | |
30 | 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 | |
31 | 00860321001410 | WP-3840 | WP-3840 | 1D Dosimetry Water Phantom | Water Phantoms with Depth Positioning Assembly | CNMC CO., INC. |
32 | 00860321001403 | WP-3040 / WP-3840 | WP-3040 | 1D Dosimetry Water Phantom. | Water Phantoms with Depth Positioning Assembly | CNMC CO., INC. |
33 | 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. | |
34 | 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. | |
35 | 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. | |
36 | 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. | |
37 | 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 | |
38 | 00860006901127 | PR071-001-R | PR071-001-R | Magnetic Resonance Imaging System, Auxiliary Rack | Promaxo MRI System | PROMAXO, INC. |
39 | 00860006901110 | PR071-001-M | PR071-001-M | Magnetic Resonance Imaging System, Magnet Cart | Promaxo MRI System | PROMAXO, INC. |
40 | 00860004785101 | v5 | FIRMM® | Framewise Integrated Real-Time MRI Monitoring | FIRMM® | NOUS IMAGING, INC. |
41 | 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. | |
42 | 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. |
43 | 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 | |
44 | 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 | |
45 | 00860001672701 | 2.0 | ClearCheck is intended for quality assessment of radiotherapy treatment plans. | ClearCheck | RADFORMATION, INC | |
46 | 00860001523218 | PFL-02PV | PFL-02PV | Personalized PseudoPatient™ PV FL | Personalized PseudoPatient™ PV | RTSAFE, INC. |
47 | 00860001523201 | PIC-02PV | PIC-02PV | Personalized PseudoPatient™ PV IC | Personalized PseudoPatient™ PV | RTSAFE, INC. |
48 | 00860000606172 | 850-11001-05 | Swoop POC MRI Scanner (Mk1.8 version) | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner | HYPERFINE RESEARCH, INC. | |
49 | 00860000606141 | V1.7 (850-11001-04) | The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device t The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI system can generate MRI data sets with a broad range of contrasts.The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery. | Swoop Point-of-Care Magnetic Resonance Imaging Scanner | HYPERFINE RESEARCH, INC. | |
50 | 00860000606134 | V1.0 (810-11049-01) | The Site Quality Assurance Phantom is specifically designed as a medical device The Site Quality Assurance Phantom is specifically designed as a medical device and augments the scanner by allowing weekly quality control checks of the functioning of the scanner in the hospital environment. | Swoop Site Quality Assurance Phantom | HYPERFINE RESEARCH, INC. |