No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00815686020064 | SYS-2000 | SYS-2000 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4 System V2, 120V, 60Hz | |
2 | 00815686020057 | SYS-1500 | SYS-1500 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNView System | |
3 | 00815686021108 | INS-5700 | INS-5700 | JAK | System, X-Ray, Tomography, Computed | SPiN EWC – Biopsy Guide Kit | ||
4 | 00815686021078 | SFT-0007 | SFT-0007 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNDrive Software Application | |
5 | 00815686020736 | INS-5600 | INS-5600 | JAK | System, X-Ray, Tomography, Computed | SPiNPerc Biopsy Needle Guide Kit | ||
6 | 00815686020071 | SYS-2230 | SYS-2230 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4 System V2, 230V, 50Hz | |
7 | 00815686020637 | INS-5410 | INS-5410 | JAK | System, X-Ray, Tomography, Computed | Always-On Tip Tracked 22ga ANSO Flexible Needle, 15mm L, 1.8mm OD | ||
8 | 00815686020590 | INS-0382 | INS-0382 | JAK | System, X-Ray, Tomography, Computed | Always-On Tip Tracked 19ga ANSO Histology Needle, 15mm L, 1.8mm OD | ||
9 | 00815686020538 | INS-0352 | INS-0352 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked Brush, 15mm L, 1.8mm OD | |
10 | 00815686020033 | SYS-0185 | SYS-0185 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNPlanning Laptop Workstation | |
11 | 00815686020446 | INS-0305 | INS-0305 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked Guidewire, 1.0mm, 950mm | |
12 | 00815686021290 | INS-5915 | INS-5915 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 180 Degrees For Use With Olympus 190 Scopes | |
13 | 00815686021269 | INS-5905 | INS-5905 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 180 Degrees For Use With Olympus Scopes | |
14 | 00815686020354 | INS-5034 | INS-5034 | JAK | System, X-Ray, Tomography, Computed | 17ga LG, 123mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
15 | 00815686020293 | INS-5028 | INS-5028 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
16 | 00815686020279 | INS-5026 | INS-5026 | JAK | System, X-Ray, Tomography, Computed | 18ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
17 | 00815686020576 | INS-0372 | INS-0372 | JAK | System, X-Ray, Tomography, Computed | Always-On Tip Tracked Forceps, 1.8mm OD, Serrated Cup | ||
18 | 00815686020477 | INS-0322 | INS-0322 | JAK | System, X-Ray, Tomography, Computed | 2 | View Peripheral Catheter, 3.2mm OD, 2.0mm WC | |
19 | 00815686021153 | INS-5900 | INS-5900 | JAK | System, X-Ray, Tomography, Computed | SPiN Access Catheter - Biopsy Guide Kit | ||
20 | 00815686021313 | INS-5925 | INS-5925 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 180 Degrees For Use With Pentax Scopes | |
21 | 00815686021276 | INS-5910 | INS-5910 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 90 Degrees For Use With Olympus 190 Scopes | |
22 | 00815686021177 | INS-5911 | INS-5911 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter, 90 Degree Catheter | |
23 | 00815686020361 | INS-5036 | INS-5036 | JAK | System, X-Ray, Tomography, Computed | 22 UTW, 125mm Always-On Tip Tracked Biopsy Needle, Trocar Point | ||
24 | 00815686020323 | INS-5031 | INS-5031 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
25 | 00815686020262 | INS-5025 | INS-5025 | JAK | System, X-Ray, Tomography, Computed | 18ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
26 | 00815686020118 | SYS-4230 | SYS-4230 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Thoracic Navigation System, 230V, 50Hz | |
27 | 00815686020088 | SYS-3000 | SYS-3000 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4 System, 120V, 60Hz | |
28 | 00815686020712 | INS-5323 | INS-5323 | JAK | System, X-Ray, Tomography, Computed | Slidding Stopper 1.4 - 1.9 OD | ||
29 | 00815686021122 | INS-5620 | INS-5620 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Kit | ||
30 | 00815686021061 | SFT-0004 | SFT-0004 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4IR Software Application | |
31 | 00815686020439 | INS-0304 | INS-0304 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Trip Tracked Guidewire, 1.0mm, 735mm | |
32 | 00815686020392 | INS-0048 | INS-0048 | JAK | System, X-Ray, Tomography, Computed | 2 | vPad2 Connector Cable | |
33 | 00815686021252 | INS-5903 | INS-5903 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Adapter, Pentax | |
34 | 00815686021160 | INS-5901 | INS-5901 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Locking Device, Olympus | |
35 | 00815686020309 | INS-5029 | INS-5029 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
36 | 00815686020255 | INS-5024 | INS-5024 | JAK | System, X-Ray, Tomography, Computed | 17ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
37 | 00815686020231 | INS-5022 | INS-5022 | JAK | System, X-Ray, Tomography, Computed | 17ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
38 | 00815686020651 | INS-5450 | INS-5450 | JAK | System, X-Ray, Tomography, Computed | SPiN Xtend 2.0mm OD, 21ga | ||
39 | 00815686020514 | INS-0342 | INS-0342 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked 20ga Aspiration Needle, 15mm L, 1.8mm OD | |
40 | 00815686021085 | SFT-0010 | SFT-0010 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNPlanning Software Application | |
41 | 00815686020927 | INS-5035 | INS-5035 | JAK | System, X-Ray, Tomography, Computed | 17ga LG, 73mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
42 | 00815686021245 | INS-5902 | INS-5902 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Adapter, Olympus 190 | |
43 | 00815686021207 | INS-5300 | INS-5300 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm OD | |
44 | 00815686020217 | INS-5016 | INS-5016 | JAK | System, X-Ray, Tomography, Computed | 17ga, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
45 | 00815686020705 | INS-5040 | INS-5040 | JAK | System, X-Ray, Tomography, Computed | Always-On TIp Tracked Universal Tracker, LG, 7-12ga | ||
46 | 00815686020644 | INS-5440 | INS-5440 | JAK | System, X-Ray, Tomography, Computed | View Peripheral Catheter, 3.8mm OD, 2.5mm WC | ||
47 | 00815686021139 | INS-5610 | INS-5610 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Localization Needle 19ga x 105mm, 1cm marking zone | ||
48 | 00815686020286 | INS-5027 | INS-5027 | JAK | System, X-Ray, Tomography, Computed | 18ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
49 | 00815686020248 | INS-5023 | INS-5023 | JAK | System, X-Ray, Tomography, Computed | 17ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
50 | 00815686020224 | INS-5017 | INS-5017 | JAK | System, X-Ray, Tomography, Computed | 17ga, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B209CAS2X10 | 2.1 | V3D-Calcium Scoring is a software application used with advanced PC hardware for V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent. | V3D-Calcium Scoring | VIATRONIX INCORPORATED | |
2 | B209CAS2X00 | 2.0 | V3D-Calcium Scoring is a software application used with advanced PC hardware for V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent. | V3D-Calcium Scoring | VIATRONIX INCORPORATED | |
3 | B209CAR1X10 | 1.1 | V3D-Cardiac is a software application used with advanced PC hardware for evaluat V3D-Cardiac is a software application used with advanced PC hardware for evaluating DICOM 3.0 compliant CT images of the human heart. It is designed to aid the physician in analyzing the heart anatomy and detecting anomalies based on contrast enhanced CT images. It provides both coronary artery tracking and left ventricle volume analyzing tools for single or multi-phase CT scan. | V3D-Cardiac | VIATRONIX INCORPORATED | |
4 | B201CGSCENERGY0 | CGSCENERGY | Clear Guide SCENERGY | CLEAR GUIDE MEDICAL, INC. | ||
5 | B201CGOHM0 | CGOHM | CG-OH-M | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | Clear Guide Optical Head | CLEAR GUIDE MEDICAL, INC. |
6 | B201CGCORE24MR0 | CGCORE24MR | CG-CORE24-MR | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
7 | B201CGCORE240 | CGCORE24 | CG-CORE24 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
8 | B201CGCORE130 | CGCORE13 | CG-CORE-13 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
9 | 86000594161101 | 9801101000 | 86000594161101 | SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquir SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head includingthe ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ),other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use indiagnostic support. The device displays two and three dimensional images for each examined anatomical region.The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. | SeeFactor CT3 | EPICA MEDICAL INNOVATIONS LLC |
10 | 60889971743572 | OnSight 3D Extremity System | 1743574 | ONSIGHT 3D EXTREMITY SYS W RMT CONSOLE | OnSight 3D Extremity System | CARESTREAM HEALTH, INC. |
11 | 60889971743565 | OnSight 3D Extremity System | 1743566 | ONSIGHT 3D EXTREMITY SYS W ATCH CONSOLE | OnSight 3D Extremity System | CARESTREAM HEALTH, INC. |
12 | 47630039301444 | 017285 | Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector | EmpowerCTA®+ Injector System 1731 ed03 | BRACCO INJENEERING SA | |
13 | 47630039301437 | 017285 | 017285 | Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
14 | 47630039301000 | 017285 | Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA | |
15 | 47630039300904 | 017285 | 017285 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 376300393004711 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300891 | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
16 | 47630039300812 | 017383 | 017383 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 376300393004711 x EDA Module Kit GTIN : 376300393004261 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300822 | EmpowerCTA®+ Injector System with EDA | BRACCO INJENEERING SA |
17 | 47630039300782 | 017285 | 017285 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 376300393004711 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300822 | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
18 | 47630039300447 | 017383 | 017383 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 376300393004711 x EDA Module Kit GTIN : 376300393004261 x EmpowerSync® Power Supply GTIN : 376300393004881 x Injector GTIN : 37630039300747 | EmpowerCTA®+ Injector System with EDA | BRACCO INJENEERING SA |
19 | 47630039300430 | 017285 | 017285 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 376300393004711 x EmpowerSync® Power Supply GTIN : 376300393004881 x Injector GTIN : 37630039300747 | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
20 | 37630039301812 | 017418 | 017418 | Injector Mounting Arm, Right | BRACCO INJENEERING SA | |
21 | 37630039301805 | 017417 | 017417 | Injector Mounting Arm, Left | BRACCO INJENEERING SA | |
22 | 37630039301737 | 015781 | EDA Clip | BRACCO INJENEERING SA | ||
23 | 37630039300709 | 017411 | 017411 | Floor Stand Shroud | BRACCO INJENEERING SA | |
24 | 37630039300693 | 017410 | 017410 | Floor Stand | BRACCO INJENEERING SA | |
25 | 37630039300686 | 015781 | 015781 | EDA Clip | BRACCO INJENEERING SA | |
26 | 37630039300679 | 017415 | 017415 | Ceiling Column Short | BRACCO INJENEERING SA | |
27 | 37630039300662 | 017414 | 017414 | Ceiling Column Medium | BRACCO INJENEERING SA | |
28 | 37630039300655 | 017413 | Ceiling Column Long | BRACCO INJENEERING SA | ||
29 | 37630039300648 | 017419 | 017419 | Ceiling Mount Adapter Plate | BRACCO INJENEERING SA | |
30 | 37630039300631 | 017418 | 017418 | Injector Mounting Arm, Right | BRACCO INJENEERING SA | |
31 | 37630039300624 | 017417 | 017417 | Injector Mounting Arm, Left | BRACCO INJENEERING SA | |
32 | 37630039300617 | 017416 | 017416 | Articulating arm | BRACCO INJENEERING SA | |
33 | 37630039300600 | 017528 | 017528 | IV pole | BRACCO INJENEERING SA | |
34 | 37630039300594 | 017527 | 017527 | Power Supply to remote USB cable | BRACCO INJENEERING SA | |
35 | 37630039300587 | 017526 | 017526 | EmpowerSync® Remote Control Pendant Switch | BRACCO INJENEERING SA | |
36 | 37630039300570 | 017524 | 017524 | Pendant Cable | BRACCO INJENEERING SA | |
37 | 37630039300563 | 017983 | 017983 | Power/Comm Cable (60’ Plenum) | BRACCO INJENEERING SA | |
38 | 37630039300556 | 017422 | 017422 | Power/Comm Cable (60’) | BRACCO INJENEERING SA | |
39 | 37630039300549 | 017523 | 017523 | EmpowerSync® Philips Scanner Interface Adapter | BRACCO INJENEERING SA | |
40 | 37630039300532 | 017613 | 017613 | Philips Scanner Cable | BRACCO INJENEERING SA | |
41 | 37630039300525 | 017521 | 017521 | Philips Brilliance Interconnect Cable | BRACCO INJENEERING SA | |
42 | 37630039300518 | 017421 | 017421 | Interconnect Power/Comm Cable (20') | BRACCO INJENEERING SA | |
43 | 37630039300501 | 017412 | 017412 | Power/Comm Cable (75') | BRACCO INJENEERING SA | |
44 | 37630039300495 | 017355 | 017355 | EmpowerSync® Cables | BRACCO INJENEERING SA | |
45 | SHZ03502022 | SHZ-035-020-22 | SHZ-035-020-22 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle. | VISICOIL MR | RADIOMED CORP |
46 | SHZ03501022 | SHZ-035-010-22 | SHZ-035-010-22 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle. | VISICOIL MR | RADIOMED CORP |
47 | SHZ03500522 | SHZ-035-005-22 | SHZ-035-005-22 | 0.35mm x 0.5cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle. | VISICOIL MR | RADIOMED CORP |
48 | 19356870000014 | XV LVAS | The XV Lung Ventilation Analysis Software is a software-based image processing t The XV Lung Ventilation Analysis Software is a software-based image processing technology that analyzes cinefluorograph images in combination with a CT image to quantify ventilation of pulmonary tissue, thereby providing support to physicians in their assessment of patients with lung diseases.The XV Lung Ventilation Analysis Software measures the tissue motion of the lung, at all locations throughout the lung, and at all phases of the breath. It uses these motion measurements to calculate the 4-dimensional (4D) ventilation of lung tissues. Quantification and statistics are provided in the form of a Report.The key outputs are:• The tidal volume (i.e. total lung ventilation), presented as a single value;• Visualization of lung ventilation with color-defined specific ventilation ranges;• The heterogeneity of lung ventilation, presented as three values; and• Ventilation graph/ histogram of the classified lung voxel’s relative frequencies including ventilation defect percentage. | XV Lung Ventilation Analysis Software | 4DMEDICAL LIMITED | |
49 | 17630039301740 | 102409 | EmpowerCTA+ 17" Remote 1731 ed 03 | remote control 1731 ed 03 | BRACCO INJENEERING SA | |
50 | 17630039301726 | 017354 | EDA Module Kit | BRACCO INJENEERING SA |