Other products from "BAYER MEDICAL CARE INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00616258025315 ART 700 HS6 ART 700 HS6 ASSY,CBL,HANDSWITCH,LR,UDI (87978486) DXT Injector And Syringe, Angiographic 2 MEDRAD® Mark 7 Arterion Handswitch 6’ Standard
2 00616258022895 FLEXS-150-QFT FLEXS-150-QFT STLNT,KIT,SYR,CT,S,QFT,FLS3,150ML,WLD (87078825) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant FLEX Syringe Kit
3 00616258022864 FLEXD-200-SCS FLEXD-200-SCS STLNT,KIT,SYR,CT,D,SCS,FLS3,200ML,WLD (87078787) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant FLEX Syringe Kit
4 00616258022857 FLEXD-200-QFT FLEXD-200-QFT STLNT,KIT,SYR,CT,D,QFT,FLS3,200ML,WLD (87078779) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant FLEX Syringe Kit
5 00616258022840 FLEXS-150-SPK FLEXS-150-SPK STLNT,KIT,SYR,CT,S,SPK,FLS3,150ML,WLD (87078760) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant FLEX Syringe Kit
6 00616258022208 SSS-QFT SSS-QFT STELLANT,KIT,SYR,CT,SNGL,QFT,MC,WLD (86698617) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
7 00616258022185 SSS-CTP-SPK SSS-CTP-SPK STLNT,KIT,SYR,CT,SNGL,60”,SPK,MC,WLD (86698242) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
8 00616258022161 SSS-CTP-QFT SSS-CTP-QFT STLNT,KIT,SYR,CT,SNGL,60”,QFT,MC,WLD (86698226) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
9 00616258021898 LP-96-T-CV LP-96-T-CV ASSY,TBG,SNGL,LPCT,T-CONN,CV,MC,WLD (86599929) DXT Injector And Syringe, Angiographic 2 Low Pressure Connector Tubing Integral "T" with Check Valve
10 00616258021492 TAG C50 HPCT TAG C50 HPCT ASSY,TBG,TWIST-GO,20”,UV,MC,WLD (86566788) FPK Tubing, Fluid Delivery 2 MEDRAD® Twist & Go Sterile High Pressure Connector Tubing. 50cm (20in)
11 00616258021461 AVA 500 MPAT (Part 2 of 2) AVA 500 MPAT (Part 2 of 2) ASSY,TBG,MULTI,ANGIO,MC,WLD (86566648) DXT Injector And Syringe, Angiographic 2 MEDRAD® Avanta Multi-Patient Disposable Set
12 00616258021034 FLEXS-150-QFT FLEXS-150-QFT STLNT,KIT,SYR,CT,S,QFT,FLS3,150ML,RW (86016346) DXT Injector And Syringe, Angiographic MEDRAD® Stellant FLEX Syringe Kit
13 00616258021003 FLEXD-200-SCS FLEXD-200-SCS STLNT,KIT,SYR,CT,D,SCS,FLS3,200ML,RW (86015889) DXT Injector And Syringe, Angiographic MEDRAD® Stellant FLEX Syringe Kit
14 00616258010670 FLEXS-150-SPK FLEXS-150-SPK Stellant Single 150mL Syringe Kit with LPDCT with T-Connector and 1 sterile spik Stellant Single 150mL Syringe Kit with LPDCT with T-Connector and 1 sterile spike (STLNT,KIT,SYR,CT,S,SPK,FLS3,150ML,RW) (85074237) IZQ,DXT Injector, Contrast Medium, Automatic,Injector And Syringe, Angiographic MEDRAD® Stellant FLEX Syringe Kit
15 00616258010663 FLEXD-150-SPK FLEXD-150-SPK STLNT,KIT,SYR,CT,D,QFT,FLS3,150ML,RW (85074229) DXT Injector And Syringe, Angiographic MEDRAD® Stellant Sterile Disposable Syringe
16 00616258010496 KMA 562-1 KMA 562-1 CABLE,FOOT SWITCH ASSY,UDI,BATCH (85594354) DXT Injector And Syringe, Angiographic 2 CABLE,FOOT SWITCH ASSY,UDI,BATCH
17 00616258010632 FLEXD-200-QFT FLEXD-200-QFT STLNT,KIT,SYR,CT,D,QFT,FLS3,200ML,RW (85074199) DXT Injector And Syringe, Angiographic MEDRAD® Stellant FLEX Syringe Kit
18 00616258010502 RPA 550-1 RPA 550-1 ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH (85594370) DXT Injector And Syringe, Angiographic 2 ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH
19 00616258010403 EHS 700 05 EHS 700 05 CBL,HANDSWITCH,5',HEAD,MCT2.0,UDI,BATCH (85591304) DXT Injector And Syringe, Angiographic 2 CBL,HANDSWITCH,5',HEAD,MCT2.0,UDI,BATCH
20 00616258010182 AVA 500 MPAT (Part 2 or 2) AVA 500 MPAT (Part 2 or 2) Avanta Multi-Patient Disposable Set(ASSY,PKG,AVANTA,MPDS w/HPFCV,MC,JA2) (85236156) DXT Injector And Syringe, Angiographic 2 MEDRAD® Avanta Multi-Patient Disposable Set
21 00616258009919 SDS-CTP-SPK SDS-CTP-SPK Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT, Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,DUAL,STLNT,APOLLO,T-CON,SPK, MC,JA2) (85231316) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
22 00616258009896 SJS-PT-J SJS-PT-J KIT,SYR,STLNT,SJS-PT-J,MC,JA2 (85231499) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
23 00616258009001 M64ERA8-HD M64ERA8-HD "8-Channel, eCoil(TM) Interface Device for GE 1.5T Excite HD(60727560)" MOS Coil, Magnetic Resonance, Specialty 2 MEDRAD® 1.5T eCoil Interface Device (for GE)
24 00616258008196 IBP TS IBP TS ASSEMBLY,FINAL,IBPTS, MC (CT - SWABBABLE VALVE TRANSFER SET, SVTS) (85199579) PQH Iodinated Contrast Media Transfer Tubing Set 2 MEDRAD® Imaging Bulk Package Transfer Set
25 00616258007953 SSS-CTP-SPK SSS-CTP-SPK Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT,SYR,STLNT,APOLLO,W/LPCT,SPK, MC, CH)(60728834) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
26 00616258007946 SSS-CTP-QFT SSS-CTP-QFT Stellant Single Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(KI Stellant Single Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(KIT,SGL,STLNT,APOLLO,W/LPCT,QFT,MC,CH)(60728796) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
27 00616258007939 SDS-CTP-SPK SDS-CTP-SPK Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT,D Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT,DUAL,STLNT,APOLLO,T-CON,SPK, MC, CH)(60728753) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
28 00616258007922 SDS-CTP-QFT SDS-CTP-QFT Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(KIT, Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(KIT,DUAL,STLNT,APOLLO,TCON,QFT,MC,CH)(60728729) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
29 00616258007830 QFT 200 QFT 200 Individually Packaged Quick Fill Tubes(PKG,TUBE,QUICK FILL,QFT 200,RAD,MC,CH)(60729296) DXT Injector And Syringe, Angiographic 2 Quick Fill Disposable Syringe Fill Tube
30 00616258007731 AVA 500 SPAT L AVA 500 SPAT L Avanta Single-Patient Disposable Set(SET,PKG,SPDS,AVA500SPAT L,US FBPIV,MC,C)(60729512) DXT Injector And Syringe, Angiographic 2 MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable
31 00616258007489 AVA 500 SPAT L AVA 500 SPAT L Avanta Single-Patient Disposable Set(SET,PKG,SPDS,AVA500SPAT L,US FBPIV,MC,LA)(60728958) DXT Injector And Syringe, Angiographic 2 MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable
32 00616258007465 SSS-CTP-SPK SSS-CTP-SPK Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT,SYR,STLNT,APOLLO,W/LPCT,SPK, MC, LA)(60728826) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
33 00616258007458 SDS-CTP-SPK SDS-CTP-SPK Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT, Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT,DUAL,STLNT,APOLLO,T-CON,SPK, MC, LA)(60728745) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
34 00616258007441 SDS-CTP-QFT SDS-CTP-QFT Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(KIT, Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(KIT,DUAL,STLNT,APOLLO,TCON,QFT,MC,LA)(60728702) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
35 00616258007212 AVA 500 SPAT L AVA 500 SPAT L "Avanta Single-Patient Disposable Set(SET,PKG,SPDS,AVA500SPAT L,US FBPIV,MC,JA)(84197017)" DXT Injector And Syringe, Angiographic 2 MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable
36 00616258007199 XDS PID XDS PID "XDS Patient Interface Disposable(Assembly, PID, Extravasation,MC,JA)(84217050)" KGX Tape And Bandage, Adhesive 1 MEDRAD® XDS Patient Interface Disposable
37 00616258007137 TAG C150 HPCT TAG C150 HPCT "Twist & Go, HPCT, CoEx, 60''(SET,PACKAGED,TWIST-GO,CO-EX, 60"",UV,MC,J)(84196975)" FPK Tubing, Fluid Delivery 2 MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in)
38 00616258007045 SDS-CTP-SPK SDS-CTP-SPK Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT,D Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT,DUAL,STLNT,APOLLO,T-CON,SPK, MC,JA)(84192961) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
39 00616258006956 TAG C150 HPCT TAG C150 HPCT Twist & Go, HPCT, CoEx, 60''(ANGIO - ART, HPCT, TWIST & GO, CO-EX, 60")(60766876) FPK Tubing, Fluid Delivery 2 MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in)
40 00616258005805 QFT 200 QFT 200 Individually Packaged Quick Fill Tubes(QUICK FILL TUBE, MC)(60729288) DXT Injector And Syringe, Angiographic 2 Quick Fill Disposable Syringe Fill Tube
41 00616258005706 PROT 50 PROT 50 MEDRAD PRO-TEKT Endorectal Balloon(PRO-TEKT Endorectal Balloon, PROT50)(60729377) EXX Probe, Rectal, Non-Powered 1 MEDRAD® PRO-TEKT Endorectal Balloon
42 00616258005645 LP-96-T-CV LP-96-T-CV Low Pressure Connector Tubing Integral 'T' with Check Valve(CT - 96" T-CONNECT T Low Pressure Connector Tubing Integral 'T' with Check Valve(CT - 96" T-CONNECT TUBING W/CHECK VALVE)(60729008) DXT Injector And Syringe, Angiographic 2 Low Pressure Connector Tubing Integral "T" with Check Valve
43 00616258005409 XDS PID XDS PID XDS Patient Interface Disposable(CT - EXTRAVASATION PID)(60727773) KGX Tape And Bandage, Adhesive 1 MEDRAD® XDS Patient Interface Disposable
44 00616258005324 AVA 500 SPAT L AVA 500 SPAT L Avanta Single-Patient Disposable Set(ANGIO-AVAN,SET,SPDS,AVA500SPAT L,US FBPIV, Avanta Single-Patient Disposable Set(ANGIO-AVAN,SET,SPDS,AVA500SPAT L,US FBPIV, MC)(60729504) DXT Injector And Syringe, Angiographic 2 MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable
45 00616258005256 SDS-CTP-SCS SDS-CTP-SCS Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(CT - Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(CT - STELLANT DUAL SYR KIT, T-CON, SCS)(60729369) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
46 00616258005225 SSS-QFT SSS-QFT Stellant Single Syringe and Quick Fill Tube(CT - STELLANT SINGLE SYR KIT, QFT)(60728842) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
47 00616258005218 SSS-CTP-SPK SSS-CTP-SPK Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(CT- Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(CT-STELLANT SINGLE SYR KIT, LPCT, SPIKE)(60728818) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
48 00616258005201 SSS-CTP-QFT SSS-CTP-QFT Stellant Single Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(CT Stellant Single Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(CT - STELLANT SINGLE SYR KIT, LPCT, QFT)(60728788) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
49 00616258005188 SDS-CTP-SPK SDS-CTP-SPK Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(CT-ST Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(CT-STELLANT DUAL SYR KIT, T-CON, SPIKES)(60728737) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
50 00616258005171 SDS-CTP-QFT SDS-CTP-QFT Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(CT - Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube(CT - STELLANT DUAL SYR KIT, T-CON, QFT)(60728699) DXT Injector And Syringe, Angiographic 2 MEDRAD® Stellant Sterile Disposable Syringe
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28 B554MRCP1000 1.0 MRCP+v1 is indicated for use as a software-based image processing system for non MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data.MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment.MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols.MRCP+v1 is suitable for all patients not contra-indicated for MRI. MRCP+ PERSPECTUM LTD
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33 B554LMS3300 3.3.0 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
34 B554LMS3200 3.2.0 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. LiverMultiScan PERSPECTUM LTD
35 B554LMS3100 3.1.0 LiverMultiScan (LMSv3) is a standalone software device. The purpose of the Liver LiverMultiScan (LMSv3) is a standalone software device. The purpose of the LiverMultiScan (LMSv3) device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). The LiverMultiScan (LMSv3) is a post-processing software device, a trained operator uses tools such as automatic liver segmentation and region of interest placement upon previously acquired MR images, from which a summary report is generated. The summary report is then sent to an interpreting clinician.The interpreting clinician needs to take into consideration the device’s limitations and accuracy during clinical interpretation.LiverMultiScan (LMSv3) is not intended to replace the established procedures for the assessment of a patients liver health by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed.The device is intended to be used by a trained operator to generate metrics for subsequent interpretation by a clinician.The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan (LMSv3) metrics. The purpose of a LiverMultiScan (LMSv3) metrics is to provide imaging information to assist in characterizing tissue in the liver, which are additional to existing methods for obtaining information relating to the liver. LiverMultiScan (LMSv3) metrics are not intended to replace any existing diagnostic source of information, but can be used to identify patients who LiverMultiScan PERSPECTUM LTD
36 B554LMS2100 2.1 LiverMultiScan is a standalone software device. The purpose of the LiverMultiSca LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision. LiverMultiScan PERSPECTUM LTD
37 B554LMS2000 2.0 LiverMultiScan is a standalone software device. The purpose of the LiverMultiSca LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision. LiverMultiScan PERSPECTUM LTD
38 B554HEPATICA100 1.0.0 Hepatica (Hepatica v1) is a post-processing medical device software that present Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient’s liver health.Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL methodfrom multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrics present numerical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient’s liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient’s liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica(Hepatica v1), may support surgical decision making. Hepatica PERSPECTUM LTD
39 B545032000000 03-2000-00 MRopen 0.5 T ASG SUPERCONDUCTORS SPA
40 B440HVCP030 030004 HVCP HeartVista Cardiac Package HeartVista Cardiac Package HEARTVISTA, INC.
41 B440HVCP020 020301 HVCP HeartVista Cardiac Package HeartVista Cardiac Package HEARTVISTA, INC.
42 B358PCI01PP0 4.1 PCI01PP Prism Process® software is used in conjunction with a Magnetic Resonance scanner Prism Process® software is used in conjunction with a Magnetic Resonance scanner to process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI), and other MRI data sets. Prism Process performs post-processing for quality control and subsequent viewing of fMRI and other data. Prism Process PRISM CLINICAL IMAGING, INC.
43 B358PCI01PA0 4.1 PCI01PA Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner Prism Acquire® software is used in conjunction with a Magnetic Resonance scanner to acquire blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned for fMRI. The patient’s responses and image data from the MRI scanner are stored for use by Prism Process. Prism Acquire PRISM CLINICAL IMAGING, INC.
44 B237ZXLASR110 ZXL-ASR-11 GE GEM MR Cart Strain Relief for Zephyr & Mayfield Skull Clamp Zephyr Patient Positioning and Transfer System DIACOR, INC.
45 B237ZXLASR100 ZXL-ASR-10 GE GEM MR Cart Strain Relief for Zephyr & DORO Skull Clamp Zephyr Patient Positioning and Transfer System DIACOR, INC.
46 B237ZXLASB060 ZXL-ASB-06 Zephyr Docking Side Stop Bar - (1): Used on GE SIGNA PET/MR FTT for Zephyr Systems Zephyr Patient Positioning and Transfer System DIACOR, INC.
47 B237ZXLASB050 ZXL-ASB-05 Zephyr Docking Side Stop Bar - (1): Used on Philips Ingenia MR-SIM Zephyr Patient Positioning and Transfer System DIACOR, INC.
48 B237ZXLADK510 ZXL-ADK-51 Zephyr Docking Kit for Philips Ingenia MR-SIM Includes (2) side stop bar and (1) Zephyr Docking Kit for Philips Ingenia MR-SIM Includes (2) side stop bar and (1) foot end stop Zephyr Patient Positioning and Transfer System DIACOR, INC.
49 B237ZXLADK500 ZXL-ADK-50 Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar a Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit for MR couch Zephyr Patient Positioning and Transfer System DIACOR, INC.
50 B237ZXLADK100 ZXL-ADK-10 Zephyr Docking Kit 50cm for GE PET/MR Flat Table Top (FTT) Zephyr Patient Positioning and Transfer System DIACOR, INC.