| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 06009880828128 | eXero-dr | CL-08-0013-H11 | The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposesin both trauma and general radiography cases as well as in forensic pathology cases. | JAK | System, X-Ray, Tomography, Computed | 2 | Lodox |
| 2 | 06009880828067 | eXero-dr | CL-08-0013-H6 | The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases. | JAK | System, X-Ray, Tomography, Computed | 2 | Lodox |
| 3 | 06009880828166 | eXero-dr | CL-08-0013-H2 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | JAK | System, X-Ray, Tomography, Computed | 2 | LODOX |
| 4 | 06009880828159 | Xmplar-dr | CL-08-0015-B2 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | JAK | System, X-Ray, Tomography, Computed | 2 | LODOX |
| 5 | 06009880828142 | eXero-dr | CL-08-0013-H4 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | JAK | System, X-Ray, Tomography, Computed | 2 | LODOX |
| 6 | 06009880828135 | Xmplar-dr | CL-08-0013-A11 | The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray images used for diagnosis purpose in both trauma and general radiography cases, as well as forensic pathology cases. | JAK | System, X-Ray, Tomography, Computed | 2 | LODOX |
| 7 | 06009880828111 | Xmplar-dr | CL-08-0015-B1 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | JAK | System, X-Ray, Tomography, Computed | 2 | LODOX |
| 8 | 06009880828104 | Xmplar-dr | CL-08-0012-A8 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | JAK | System, X-Ray, Tomography, Computed | 2 | LODOX |
| 9 | 06009880828098 | Xmplar-dr | CL-08-0012 | The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ra The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiology cases, as well as forensic pathology cases. | JAK | System, X-Ray, Tomography, Computed | 2 | LODOX |
| 10 | 06009880828081 | eXero-dr | CL-08-0016-I2 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | JAK | System, X-Ray, Tomography, Computed | 2 | LODOX |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 03760305400086 | 30-0001 | 30-0001-01-USA | The EPIONE device is a user controlled, stereotactic accessory intended to assis The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures | EPIONE | QUANTUM SURGICAL |
| 2 | 03760305400079 | 02-0044 | 02-0044 | The Navigation Probe is an instrument of the EPIONE device. It enables visualizi The Navigation Probe is an instrument of the EPIONE device. It enables visualizingreference points or anatomical landmarks in the medical images. It allows the verificationof patient registration accuracy, using external anatomical landmarks or skin markers. | Short Navigation Probe | QUANTUM SURGICAL |
| 3 | 03760305400062 | 02-0027 | 02-0027-19G | The Needle Guide is an instrument of the EPIONE device. It provides mechanical g The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications. | Needle Guide | QUANTUM SURGICAL |
| 4 | 03760305400055 | 02-0031 | 02-0031 | The Navigation Probe is an instrument of the EPIONE device. It enables visualizi The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verificationof patient registration accuracy, using external anatomical landmarks or skin markers. | Navigation probe | QUANTUM SURGICAL |
| 5 | 03760305400024 | 02-0026 | 02-0026 | The Patient Reference is an instrument of the EPIONE device used to track the pa The Patient Reference is an instrument of the EPIONE device used to track the patientposition and motions including breathing. | Patient Reference | QUANTUM SURGICAL |
| 6 | 03760263520017 | 6.0 | LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qual LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to:- visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)- generate automatic reports. | LMS-Lung/TRACK | MEDIAN TECHNOLOGIES | |
| 7 | EIBAVC110030PL0 | VC-110-030-PL | VC-110-030-PL | 1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 8 | EIBAVC110020PL300 | VC-110-020-PL30 | VC-110-020-PL30 | 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 9 | EIBAVC110020PL0 | VC-110-020-PL | VC-110-020-PL | 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 10 | EIBAVC110010PL300 | VC-110-010-PL30 | VC-110-010-PL30 | 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 11 | EIBAVC110010PL0 | VC-110-010-PL | VC-110-010-PL | 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 12 | EIBAVC110005PL0 | VC-110-005-PL | VC-110-005-PL | 1.10mm x 0.5cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 13 | EIBAVC075030PL0 | VC-075-030-PL | VC-075-030-PL | 0.75mm x 3.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 14 | EIBAVC075020PL300 | VC-075-020-PL30 | VC-075-020-PL30 | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 15 | EIBAVC075020PL120 | VC-075-020-PL12 | VC-075-020-PL12 | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 16 | EIBAVC075020PL0 | VC-075-020-PL | VC-075-020-PL | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 17 | EIBAVC075010PL300 | VC-075-010-PL30 | VC-075-010-PL30 | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 18 | EIBAVC075010PL120 | VC-075-010-PL12 | VC-075-010-PL12 | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 19 | EIBAVC075010PL0 | VC-075-010-PL | VC-075-010-PL | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 20 | EIBAVC075005PL300 | VC-075-005-PL30 | VC-075-005-PL30 | 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 21 | EIBAVC075005PL120 | VC-075-005-PL12 | VC-075-005-PL12 | 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 22 | EIBAVC075005PL0 | VC-075-005-PL | VC-075-005-PL | 0.75mm x 0.50cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 23 | EIBAVC050020PLSL0 | VC-050-020-PLSL | VC-050-020-PLSL | 0.50mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 24 | EIBAVC050020PL0 | VC-050-020-PL | VC-050-020-PL | 0.5mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 25 | EIBAVC050010PLSL0 | VC-050-010-PLSL | VC-050-010-PLSL | 0.5mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 26 | EIBAVC050010PL300 | VC-050-010-PL30 | VC-050-010-PL30 | 0.5mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 27 | EIBAVC050010PL0 | VC-050-010-PL | VC-050-010-PL | 0.50mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 28 | EIBAVC050005PLSL0 | VC-050-005-PLSL | VC-050-005-PLSL | 0.50mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 29 | EIBAVC050005PL300 | VC-050-005-PL30 | VC-050-005-PL30 | 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 30 | EIBAVC050005PL0 | VC-050-005-PL | VC-050-005-PL | 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 31 | EIBAVC035040PL0 | VC-035-040-PL | VC-035-040-PL | 0.35mm x 4.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 32 | EIBAVC035030PL0 | VC-035-030-PL | VC-035-030-PL | 0.35mm x 3.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 33 | EIBAVC035020PL0 | VC-035-020-PL | VC-035-020-PL | 0.35mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 34 | EIBAVC035010PL0 | VC-035-010-PL | VC-035-010-PL | 0.35mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 35 | EIBAVC035005PL0 | VC-035-005-PL | VC-035-005-PL | 0.35mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 36 | EIBASNMR03503022200 | SNMR-035-030-2220 | SNMR-035-030-2220 | 0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. | VISICOIL MR | RADIOMED CORP |
| 37 | EIBASNMR03502022200 | SNMR-035-020-2220 | SNMR-035-020-2220 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. | VISICOIL MR | RADIOMED CORP |
| 38 | EIBASNMR03502022150 | SNMR-035-020-2215 | SNMR-035-020-2215 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachyt 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. | VISICOIL MR | RADIOMED CORP |
| 39 | EIBASNMR03502022080 | SNMR-035-020-2208 | SNMR-035-020-2208 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. | VISICOIL MR | RADIOMED CORP |
| 40 | EIBASNMR03501022200 | SNMR-035-010-2220 | SNMR-035-010-2220 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. | VISICOIL MR | RADIOMED CORP |
| 41 | EIBASNMR03501022150 | SNMR-035-010-2215 | SNMR-035-010-2215 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachyt 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. | VISICOIL MR | RADIOMED CORP |
| 42 | EIBASNMR03501022080 | SNMR-035-010-2208 | SNMR-035-010-2208 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. | VISICOIL MR | RADIOMED CORP |
| 43 | EIBASN050020PL150 | SN-050-020-PL15 | SN-050-020-PL15 | 0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 44 | EIBASN050020PL080 | SN-050-020-PL08 | SN-050-020-PL08 | 0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 45 | EIBASN050010PL150 | SN-050-010-PL15 | SN-050-010-PL15 | 0.50mm x 1.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 46 | EIBASN050010PL080 | SN-050-010-PL08 | SN-050-010-PL08 | 0.50mm x 1.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 47 | EIBASN050005PL150 | SN-050-005-PL15 | SN-050-005-PL15 | 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 48 | EIBASN050005PL080 | SN-050-005-PL08 | SN-050-005-PL08 | 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 49 | EIBASN035020PL150 | SN-035-020-PL15 | SN-035-020-PL15 | 0.35mm x 2.0cm VISICOIL loaded in an 22 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 50 | EIBASN035020PL080 | SN-035-020-PL08 | SN-035-020-PL08 | 0.35mm x 2.0cm VISICOIL loaded in an 22 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |