| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00840682144209 | 5777746 | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | NA | ||
| 2 | 00840682119658 | 5421698 | IZL | System, x-ray, mobile | 2 | NA | ||
| 3 | 00195278003348 | Navigate | AMX Navigate Designated Medical Device Assembly | IZL,MQB | System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) | 2 | AMX | |
| 4 | 00840682121071 | 4343 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Flashpad HD | ||
| 5 | 00840682120982 | 600FP | JAA | System, x-ray, fluoroscopic, image-intensified | 2 | Precision | ||
| 6 | 00840682120807 | 3543 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Flashpad HD | ||
| 7 | 00840682120784 | 2530 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Flashpad HD | ||
| 8 | 00840682119238 | 500D | JAA | System, x-ray, fluoroscopic, image-intensified | 2 | Precision | ||
| 9 | 00840682143974 | 5607000-2 | KPS | System, tomography, computed, emission | 2 | O560 to 610 Upgrade | ||
| 10 | 10840682142875 | 690 VCT Boost Upgrade | KPS | System, tomography, computed, emission | 2 | Discovery PET CT | ||
| 11 | 00840682116732 | 5340000-7 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FlashPad | ||
| 12 | 00840682116701 | 5340000-8 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FlashPad | ||
| 13 | 00840682125574 | Discovery CT A | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 14 | 00840682146616 | Apex | 5590000-20 | Revolution Apex - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
| 15 | 00840682146357 | OpenOC16 Console Upgrade | KPS | System, tomography, computed, emission | 2 | Discovery IQ | ||
| 16 | 00840682143981 | 5607000 | KPS | System, tomography, computed, emission | 2 | O560 to D600 Upgrade | ||
| 17 | 00840682143646 | CT with Apex edition | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 18 | 00840682142601 | 2 | JAK | System, x-ray, tomography, computed | 2 | SnapShot Freeze | ||
| 19 | 00840682140713 | CT with Quantix Upgrade | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 20 | 00840682138796 | 160mm Detector Upgrade | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 21 | 00840682123471 | CT ES | 5590000-15 | Revolution CT ES - Designated Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
| 22 | 00840682118552 | CT | 5590000-6 | Revolution CT - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
| 23 | 00840682104364 | 5000 | KPR,MQB | System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager) | 2 | Definium | ||
| 24 | 00840682102490 | Discovery CT | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 25 | 00840682125703 | IQ 2.0 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
| 26 | 00840682136709 | XR656 HD Upgrade | XR656HD UDI Label | KPR,MQB | System, X-Ray, Stationary,Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Discovery | |
| 27 | 00840682103107 | IQ | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | Discovery | ||
| 28 | 00840682146166 | MI Digital Ready | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
| 29 | 00840682143523 | MI | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
| 30 | 00840682120975 | MI Digital Ready | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
| 31 | 00840682108218 | MI | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
| 32 | 00840682103053 | PETCT 610 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
| 33 | 00840682102995 | PETCT 710 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
| 34 | 00195278098603 | MI | PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manuf PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | Discovery | |
| 35 | 00840682146319 | with Apex edition | JAK | System, x-ray, tomography, computed | 2 | Revolution CT | ||
| 36 | 00840682141994 | 2.0 | KPS | System, tomography, computed, emission | 2 | Discovery MI Columbird mE2 Application SW | ||
| 37 | 00840682123686 | XR240amx HD Upgrade | IZL,MQB | System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) | 2 | Optima | ||
| 38 | 00840682142168 | XR646 HD Upgrade | KPR,MQB | System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager) | 2 | Optima | ||
| 39 | 00840682147316 | TS-RT-100 | TS-RT-100 | Replacement Tape Blue for TruSignal AllFit sensor, 100 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
| 40 | 00840682147309 | TS-RTW-100 | TS-RTW-100 | Replacement Tape Wide for TruSignal Wrap and Sensitive Skin sensor, 100 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
| 41 | 00840682147293 | TS-RWM-24 | TS-RWM-24 | Replacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
| 42 | 00840682147286 | TS-HB-3 | TS-HB-3 | Replacement Headband for TruSignal Ear sensor, 3 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
| 43 | 00840682147279 | TS-RWS-24 | TS-RWS-24 | Replacement Foam Wrap Small for TruSignal Sensitive Skin sensor, 24 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
| 44 | 00840682147262 | TS-RTB-100 | TS-RTB-100 | Replacement Tape Bear for TruSignal AllFit sensor, 100 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
| 45 | 00840682147255 | TS-RWL-24 | TS-RWL-24 | Replacement Foam Wrap for TruSignal Wrap sensor, 24 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
| 46 | 00840682147248 | TS-SND-3 | TS-SND-3 | Infant Foam Sandal Wrap for TruSignal Sensitive Skin sensor, 3 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
| 47 | 00840682147231 | PACS 1.0 | Designated Medical Device, Critical Care Suite PACS 1.0 | QFM | Radiological computer-assisted prioritization software for lesions | 2 | Critical Care Suite | |
| 48 | 00840682146340 | 1.0 | QFM,KPS | Radiological computer-assisted prioritization software for lesions,System, tomog Radiological computer-assisted prioritization software for lesions,System, tomography, computed, emission | 2 | Critical Care Suite | ||
| 49 | 00840682145749 | XR240amx HD Upgrade Gen2 | MQB,IZL | Solid state x-ray imager (flat panel/digital imager),System, x-ray, mobile | 2 | Optima | ||
| 50 | 00840682122351 | XR240amx | IZL,MQB | System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) | 2 | Optima |
| 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 |