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 | 09369999026356 | 15 vials (0 to 3.2 mM) | Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aq Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydrochloride acid solution. To be used for re-verification of MRI scanner for the use of R2-MRI Analysis System (FerriScan) | FerriScan Phantom Pack | RESONANCE HEALTH ANALYSIS SERVICES PTY LTD | |
2 | 09120105730464 | V2.11 | The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. | KOALA | IB LAB GMBH | |
3 | 09120105730037 | V2.05 | The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. | KOALA | IB LAB GMBH | |
4 | 09120074399990 | 999 | TEST TEST TEST | IT-V MEDIZINTECHNIK GMBH | ||
5 | 09120074398528 | P10107-852 | System M STEP | IT-V MEDIZINTECHNIK GMBH | ||
6 | 09120074398511 | P10107-851 | M STEP Base Patient Positioning Package | IT-V MEDIZINTECHNIK GMBH | ||
7 | 09120074398504 | P10107-850 | System M STEP | IT-V MEDIZINTECHNIK GMBH | ||
8 | 09120074398115 | P10107-811 | Knee Support Cushion | IT-V MEDIZINTECHNIK GMBH | ||
9 | 09120074397996 | P10107-799 | System ProSTEP Short PC MR low | IT-V MEDIZINTECHNIK GMBH | ||
10 | 09120074397989 | P10107-798 | System ProSTEP Mask | IT-V MEDIZINTECHNIK GMBH | ||
11 | 09120074397972 | P10107-797 | System ProSTEP Short PC MR | IT-V MEDIZINTECHNIK GMBH | ||
12 | 09120074397965 | P10107-796 | System ProSTEP Short Carbon | IT-V MEDIZINTECHNIK GMBH | ||
13 | 09120074397941 | P10107-794 | System ProSTEP PC MR low | IT-V MEDIZINTECHNIK GMBH | ||
14 | 09120074397934 | P10107-793 | System HeadSTEP Bite MR | IT-V MEDIZINTECHNIK GMBH | ||
15 | 09120074397927 | P10107-792 | System FoamSTEP Plus | IT-V MEDIZINTECHNIK GMBH | ||
16 | 09120074397910 | P10107-791 | System HeadSTEP Bite Wide | IT-V MEDIZINTECHNIK GMBH | ||
17 | 09120074397903 | P10107-790 | System BodySTEP | IT-V MEDIZINTECHNIK GMBH | ||
18 | 09120074397897 | P10107-789 | System HeadSTEP Bite Narrow | IT-V MEDIZINTECHNIK GMBH | ||
19 | 09120074397880 | P10107-788 | System ProSTEP Short ABS | IT-V MEDIZINTECHNIK GMBH | ||
20 | 09120074397873 | P10107-787 | System ProSTEP Leg | IT-V MEDIZINTECHNIK GMBH | ||
21 | 09120074397866 | P10107-786 | System ProSTEP Elbow | IT-V MEDIZINTECHNIK GMBH | ||
22 | 09120074397859 | P10107-785 | System ProSTEP Brachy | IT-V MEDIZINTECHNIK GMBH | ||
23 | 09120074397842 | P10107-784 | System FoamSTEP | IT-V MEDIZINTECHNIK GMBH | ||
24 | 09120074397835 | P10107-783 | System ProSTEP PC MR | IT-V MEDIZINTECHNIK GMBH | ||
25 | 09120074397828 | P10107-782 | System ProSTEP ABS Low | IT-V MEDIZINTECHNIK GMBH | ||
26 | 09120074397811 | P10107-781 | System ProSTEP Carbon | IT-V MEDIZINTECHNIK GMBH | ||
27 | 09120074397804 | P10107-780 | System ProSTEP ABS | IT-V MEDIZINTECHNIK GMBH | ||
28 | 09120074397729 | P10107-772 | System LithoSTEP | IT-V MEDIZINTECHNIK GMBH | ||
29 | 09120074397712 | P10107-771 | System WingSTEP US High | IT-V MEDIZINTECHNIK GMBH | ||
30 | 09120074397705 | P10107-770 | System WingSTEP US Low | IT-V MEDIZINTECHNIK GMBH | ||
31 | 09120074397606 | P10107-760 | System BellySTEP | IT-V MEDIZINTECHNIK GMBH | ||
32 | 09120074397583 | P10107-758 | System TBI STEP 2,4m for Varian | IT-V MEDIZINTECHNIK GMBH | ||
33 | 09120074397576 | P10107-757 | System TBI STEP 2,4m | IT-V MEDIZINTECHNIK GMBH | ||
34 | 09120074397552 | P10107-755 | System WingSTEP M Low | IT-V MEDIZINTECHNIK GMBH | ||
35 | 09120074397545 | P10107-754 | System WingSTEP MR - High - Ball Joint | IT-V MEDIZINTECHNIK GMBH | ||
36 | 09120074397538 | P10107-753 | System WingSTEP MR - Low - Ball Joint | IT-V MEDIZINTECHNIK GMBH | ||
37 | 09120074397521 | P10107-752 | System WingSTEP M - Low - Ball Joint | IT-V MEDIZINTECHNIK GMBH | ||
38 | 09120074397514 | P10107-751 | System WingSTEP Carbon Low - Pin Joint | IT-V MEDIZINTECHNIK GMBH | ||
39 | 09120074397507 | P10107-750 | System WingSTEP Carbon High - Pin Joint | IT-V MEDIZINTECHNIK GMBH | ||
40 | 09120074397491 | P10107-749 | System WingSTEP Carbon Low - Ball Joint | IT-V MEDIZINTECHNIK GMBH | ||
41 | 09120074397484 | P10107-748 | System ProSTEP Ankle | IT-V MEDIZINTECHNIK GMBH | ||
42 | 09120074397477 | P10107-747 | System WingSTEP Carbon High - Ball Joint | IT-V MEDIZINTECHNIK GMBH | ||
43 | 09120074397460 | P10107-746 | System WingSTEP Low for Varian - Ball Joint | IT-V MEDIZINTECHNIK GMBH | ||
44 | 09120074397453 | P10107-745 | System WingSTEP High for Varian - Ball Joint | IT-V MEDIZINTECHNIK GMBH | ||
45 | 09120074397446 | P10107-744 | System WingSTEP High - HS IMRT - Ball Joint | IT-V MEDIZINTECHNIK GMBH | ||
46 | 09120074397439 | P10107-743 | System WingSTEP High - Ball Joint | IT-V MEDIZINTECHNIK GMBH | ||
47 | 09120074397422 | P10107-742 | System WingSTEP Low - Ball Joint | IT-V MEDIZINTECHNIK GMBH | ||
48 | 09120074397415 | P10107-741 | System WingSTEP High - Pin Joint | IT-V MEDIZINTECHNIK GMBH | ||
49 | 09120074397408 | P10107-740 | System WingSTEP Low - Pin Joint | IT-V MEDIZINTECHNIK GMBH | ||
50 | 09120074397316 | P10107-731 | System HeelSTEP light | IT-V MEDIZINTECHNIK GMBH |