No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10841962113998 | RT-1804 | RT-1804 | Aquaplast RT Sheet, 24" x 36", 3.2mm, Solid, XS | IYE | Accelerator, linear, medical | 2 | Aquaplast RT™ |
2 | 10841962105740 | RT-1889KSD-S3 | RT-1889KSD-S3 | Fibreplast Splt Hd Only S-Frame Gap, 3.2mm | IYE | Accelerator, linear, medical | 2 | Fibreplast™ |
3 | 10841962102428 | RT-1782S | RT-1782S | Aquaplast RT Reloadable Hd+Shldr S-Frame, 2.4mm | IYE | Accelerator, linear, medical | Aquaplast RT™ | |
4 | 10841962119198 | RT-4517-7070F20 | RT-4517-7070F20 | VacQfix Cushion, 70cm x 70cm, 20L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
5 | 10841962119358 | RT-4517-T7993F20M | RT-4517-T7993F20M | VacQfix Cushion 79cm x 93cm, 20L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
6 | 10841962119341 | RT-4517-T7993F20 | RT-4517-T7993F20 | VacQfix Cushion 79cm x 93cm, 20L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
7 | 10841962119334 | RT-4517-T6565F7M | RT-4517-T6565F7M | VacQfix Cushion, 65cm x 65cm, T-Shaped, 7L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
8 | 10841962119327 | RT-4517-T6565F7 | RT-4517-T6565F7 | VacQfix Cushion, 65cm x 65cm, T-Shaped , 7L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
9 | 10841962119310 | RT-4517-PB4M | RT-4517-PB4M | VacQfix Cushion, 96 X 55cm, 15L Fill | JAI | Couch, Radiation Therapy, Powered | 2 | VacQfix™ |
10 | 10841962119303 | RT-4517-PB4 | RT-4517-PB4 | VacQfix Cushion, 96 x 55 cm, 15L Fill | JAI | Couch, Radiation Therapy, Powered | 2 | VacQfix™ |
11 | 10841962119297 | RT-4517-PB3M | RT-4517-PB3M | VacQfix Cushion, 96 X 55cm, 12L Fill | JAI | Couch, Radiation Therapy, Powered | 2 | VacQfix™ |
12 | 10841962119280 | RT-4517-PB3 | RT-4517-PB3 | VacQfix Cushion, 96 x 55 cm, 12L Fill | JAI | Couch, Radiation Therapy, Powered | 2 | VacQfix™ |
13 | 10841962119273 | RT-4517-PB2M | RT-4517-PB2M | VacQfix Cushion, Prone Breast Cushion Without Contralateral Breast Support | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
14 | 10841962119266 | RT-4517-PB2 | RT-4517-PB2 | VacQfix Cushion, Prone Breast Cushion Without Contralateral Breast Support | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
15 | 10841962119259 | RT-4517-PB1M | RT-4517-PB1M | VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
16 | 10841962119242 | RT-4517-PB1 | RT-4517-PB1 | VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
17 | 10841962119235 | RT-4517-IND01 | RT-4517-IND01 | VacQFix Indexer | JAI | Couch, Radiation Therapy, Powered | 2 | VacQfix™ |
18 | 10841962119228 | RT-4517-80150F65M | RT-4517-80150F65M | VacQfix Cushion, 150cm x 80cm, 65L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
19 | 10841962119211 | RT-4517-80150F65 | RT-4517-80150F65 | VacQfix Cushion, 150cm x 80cm, 65L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
20 | 10841962119204 | RT-4517-7070F20M | RT-4517-7070F20M | VacQfix Cushion, 70cm x 70cm, 20L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
21 | 10841962119181 | RT-4517-70230F65FM | RT-4517-70230F65FM | Vac Q-Fix Cushion 70 x 230 , 65L fill (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
22 | 10841962119174 | RT-4517-70230F65F | RT-4517-70230F65F | VacQfix Cushion 70 x 230 , 65L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
23 | 10841962119167 | RT-4517-70150F60M | RT-4517-70150F60M | VacQfix Cushion 70cm x 150cm 60L | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
24 | 10841962119150 | RT-4517-70150F60 | RT-4517-70150F60 | VacQfix Cushion, 70cm x 150cm, 60L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
25 | 10841962119143 | RT-4517-70120F40M | RT-4517-70120F40M | Vac-Q-Fix Cushion, 120xm x 70cm, 40L Fill Gen.II (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
26 | 10841962119136 | RT-4517-70120F40 | RT-4517-70120F40 | VacQfix Cushion, 120xm x 70cm, 40L Fill Gen.II | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
27 | 10841962119129 | RT-4517-5070F15M | RT-4517-5070F15M | VacQfix Cushion, 50cm x 70cm, 15L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
28 | 10841962119112 | RT-4517-5070F15 | RT-4517-5070F15 | VacQfix Cushion, 50cm x 70cm, 15L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
29 | 10841962119105 | RT-4517-4080F15M | RT-4517-4080F15M | VacQfix Cushion, 40cm x 80cm, 15L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
30 | 10841962119099 | RT-4517-4080F15 | RT-4517-4080F15 | VacQfix Cushion, 40cm x 80cm, 15L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
31 | 10841962119082 | RT-4517-4079VF15M | RT-4517-4079VF15M | VacQfix Cushion 40cm x 80cm, 15L Fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
32 | 10841962119075 | RT-4517-4079VF15 | RT-4517-4079VF15 | VacQfix Cushion, 40cm x 79cm, 15L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
33 | 10841962119068 | RT-4517-2535F2.0M | RT-4517-2535F2.0M | Vac-Q-Fix Cushion, 25cm x 35cm, 2.0L fill (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
34 | 10841962119051 | RT-4517-2535F2.0 | RT-4517-2535F2.0 | VacQfix Cushion, 25cm x 35cm, 2.0L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
35 | 10841962119044 | RT-4517-2535F1.5M | RT-4517-2535F1.5M | Vac-Q-Fix Cushion, 25cm x 35cm, 1.5L fill (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
36 | 10841962119037 | RT-4517-2535F1.5 | RT-4517-2535F1.5 | VacQfix Cushion, 25cm x 35cm, 1.5L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
37 | 10841962119020 | RT-4517-230120T80F90M | RT-4517-230120T80F90M | VacQfix Cushion, 120/20cm x 230cm,90L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
38 | 10841962119013 | RT-4517-230120T80F90 | RT-4517-230120T80F90 | VacQfix Cushion, 120/80cm x 230cm, 90L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
39 | 10841962119006 | RT-4517-12075F35M | RT-4517-12075F35M | Vac-Q-Fix Cushion 120cm x 75cm, 35L Fill (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
40 | 10841962118993 | RT-4517-12075F35 | RT-4517-12075F35 | VacQfix Cushion 120cm x 75cm, 35L Fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
41 | 10841962118986 | RT-4517-10070F43M | RT-4517-10070F43M | Vac-Q-Fix Cushion, 100cm x 70cm, 43L fill (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
42 | 10841962118979 | RT-4517-10070F43 | RT-4517-10070F43 | VacQfix Cushion, 100cm x 70cm, 43L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
43 | 10841962118962 | RT-4517-10070F40M | RT-4517-10070F40M | VacQfix Cushion, 100cm x 70cm, 40L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
44 | 10841962118955 | RT-4517-10070F40 | RT-4517-10070F40 | VacQfix Cushion, 100cm x 70cm, 40L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
45 | 10841962118948 | RT-4517-10070F35M | RT-4517-10070F35M | VacQfix Cushion, 100cm x70cm, 35 liter Fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
46 | 10841962118931 | RT-4517-10070F35 | RT-4517-10070F35 | VacQfix Cushion, 100 cm x 70 cm 35 liter Fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
47 | 10841962118924 | RT-4517-10070F30M | RT-4517-10070F30M | VacQfix Cushion, 100cm x 70cm, 30L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
48 | 10841962118917 | RT-4517-10070F30 | RT-4517-10070F30 | VacQfix Cushion, 100cm x 70cm, 30L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
49 | 10841962118900 | RT-4517-100220F120M | RT-4517-100220F120M | VacQfix Cushion, 100cm x 220cm, 120L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
50 | 10841962118894 | RT-4517-100220F120 | RT-4517-100220F120 | VacQfix Cushion, 100cm x 220cm, 120L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00869346000200 | MobiCT-32 | MobiCT-32 | AIRO® Computed Tomography (CT) X-ray System | Airo® | MOBIUS IMAGING, LLC |
2 | 00868466000237 | IQQA-Guide | IQQA-Guide is intended for intra-operative guidance for surgical procedures | EDDA TECHNOLOGY | EDDA TECHNOLOGY, INC. | |
3 | 00868029000391 | 23820 | Head Coil (Receive Only) | VIEWRAY INCORPORATED | ||
4 | 00868029000360 | 14774 | Medium Torso Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
5 | 00868029000360 | 14774 | Medium Torso Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
6 | 00868029000353 | 14775 | Head Neck Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
7 | 00868029000353 | 14775 | Head Neck Coil (Receive Only) – Top | VIEWRAY INCORPORATED | ||
8 | 00868029000346 | 20000-01 | MRIdian Linac System | VIEWRAY INCORPORATED | ||
9 | 00868029000346 | 20000-01 | MRIdian Linac System | VIEWRAY INCORPORATED | ||
10 | 00868029000315 | 12981 | Medium Torso Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
11 | 00868029000315 | 12981 | Medium Torso Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
12 | 00868029000308 | 11765 | Head Neck Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
13 | 00868029000308 | 11765 | Head Neck Coil (Receive Only) – Bottom | VIEWRAY INCORPORATED | ||
14 | 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 | |
15 | 00867170000106 | VS5060 | Vascular Flow Analysis System | NOVA | VASSOL, INC. | |
16 | 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. |
17 | 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. |
18 | 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. |
19 | 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. |
20 | 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. |
21 | 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. |
22 | 00864687000247 | 2017 | The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SP The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files.Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies. | Cedars-Sinai Cardiac Suite | CEDARS-SINAI MEDICAL CENTER | |
23 | 00864687000223 | 2015 | The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SP The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files.Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies. | Cedars-Sinai Cardiac Suite | CEDARS-SINAI MEDICAL CENTER | |
24 | 00864687000209 | 2015 | The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SP The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files.Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies. | Cedars-Sinai Cardiac Suite | CEDARS-SINAI MEDICAL CENTER | |
25 | 00864366000124 | S250i | MEVION S250i | MEVION S250i | MEVION MEDICAL SYSTEMS, INC. | |
26 | 00864366000100 | S250 | MEVION S250 | Proton Beam Radiation Therapy System | Mevion Medical Systems | MEVION MEDICAL SYSTEMS, INC. |
27 | 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 | |
28 | 00863274000318 | R1.1 | Proton Therapy System | ProNova SC360 | PRONOVA SOLUTIONS, LLC | |
29 | 00863274000301 | R1.0 | Proton Therapy System | PRONOVA SC360 | PRONOVA SOLUTIONS, LLC | |
30 | 00863152000355 | 1030-230 | Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of upper extremities. | LineUP | CURVEBEAM, LLC | |
31 | 00863152000348 | 1030-115 | Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of Weight Bearing CT Imaging for Foot, Ankle, and Knee. Non-Load Bearing imaging of upper extremities. | LineUP | CURVEBEAM, LLC | |
32 | 00863152000331 | 1020-230 | Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible wi Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 230 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software. | In Reach | CURVEBEAM, LLC | |
33 | 00863152000324 | 1020-115 | Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible wi Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 115 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software. | In Reach | CURVEBEAM, LLC | |
34 | 00863152000317 | 1000-230 | Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot an Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot and ankle. Compatible with 230 Volts power outlet. 3D field of view of 20 cm (height) x 35 cm (diameter) accommodates weight bearing, bilateral imaging of both entire feet/ankles. Built-in cushioned seat allows for non-weight bearing imaging. Handlebars assist patients with entry into and exit from device. Scan time is 48 seconds or less. Scans are output as DICOM compatible 3D reconstructions, 0.3 mm multi-planar slices. PedCAT system includes acquisition station and visualization station enabled with CubeVue visualization software. | PedCAT | CURVEBEAM, LLC | |
35 | 00863152000300 | 1000-115 | Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot an Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot and ankle. Compatible with 115 Volts power outlet. 3D field of view of 20 cm (height) x 35 cm (diameter) accommodates weight bearing, bilateral imaging of both entire feet / ankles. Built-in cushioned seat allows for non-weight bearing imaging. Handlebars assist patients with entry into and exit from device. Scan time is 48 seconds or less. Scans are output as DICOM compatible 3D reconstructions, 0.3 mm multi-planar slices. PedCAT system includes acquisition station and visualization station enabled with CubeVue visualization software. | PedCAT | CURVEBEAM, LLC | |
36 | 00862694000304 | TMS-MRI-3500wb-02 | PICA Whole-body MRI System | TIME MEDICAL SYSTEMS | ||
37 | 00862611000349 | 3.0 | ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies.The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose). | ImagenSPECT | CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C. | |
38 | 00862611000332 | 2.0 | ImagenUniversal is a Windows application that allows physicians and healthcare p ImagenUniversal is a Windows application that allows physicians and healthcare professionals to correct myocardial perfusion PET images for transmission and emission misregistration, prompt gamma events, photon scatter and image noise. | ImagenUniversal | CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C. | |
39 | 00862611000318 | 2.2 | ImagenPRO is a software application installed on desktop computers with allows p ImagenPRO is a software application installed on desktop computers with allows physicians and healthcare professionals to inspect, reconstruct, and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angels. | ImagenPRO | CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C. | |
40 | 00862611000301 | 2.0 | The ImagenSPECT™ system is a software application that provides a processing env The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy. | ImagenSPECT | CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C. | |
41 | 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. |
42 | 00861552000418 | 1001 | Radiance 330 Proton Therapy System | Radiance 330 | PROTOM INTERNATIONAL HOLDING CORPORATION | |
43 | 00861396000308 | MOBETRON | The MOBETRON is intended for use as an Electron Beam source inside an Operating The MOBETRON is intended for use as an Electron Beam source inside an Operating Room for Electron Beam IORT. Electron beam IORT (Intra-Operative Radiation Therapy) is the use of electron radiation during surgery to treat both malignant and benign tumors. The Mobetron is not intended for unrestricted beam production. Extensive beam testing should be done in a stray radiation shielded room or a strictly controlled area. MOBETRON S/N: 72 | MOBETRON | INTRAOP MEDICAL CORPORATION | |
44 | 00861334000339 | 6.8.0 | DoseLab Pro | Dosimetry QA Software | DoseLab Pro | VARIAN MEDICAL SYSTEMS, INC. |
45 | 00861334000315 | 2.0.1 | Mobius3D | Secondary Check QA Software | Mobius3D | VARIAN MEDICAL SYSTEMS, INC. |
46 | 00861333000309 | 12 | DELTAmanager is a software package that provides display, review, and communicat DELTAmanager is a software package that provides display, review, and communications for Nuclear Medicine, Molecular Imaging, and PET/CT images. DELTAmanager may be used for remote reading on a stand alone workstation or as a plug-in on a PACS workstation. | DELTAmanager | MEDIMAGE, INC. | |
47 | 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 | |
48 | 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 | |
49 | 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 | |
50 | 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 |