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 | 00815686021146 | INS-5611 | INS-5611 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Localization Needle 19ga x 105mm, 2cm marking zone | ||
24 | 00815686020361 | INS-5036 | INS-5036 | JAK | System, X-Ray, Tomography, Computed | 22 UTW, 125mm Always-On Tip Tracked Biopsy Needle, Trocar Point | ||
25 | 00815686020323 | INS-5031 | INS-5031 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
26 | 00815686020262 | INS-5025 | INS-5025 | JAK | System, X-Ray, Tomography, Computed | 18ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
27 | 00815686020118 | SYS-4230 | SYS-4230 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Thoracic Navigation System, 230V, 50Hz | |
28 | 00815686020088 | SYS-3000 | SYS-3000 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4 System, 120V, 60Hz | |
29 | 00815686020712 | INS-5323 | INS-5323 | JAK | System, X-Ray, Tomography, Computed | Slidding Stopper 1.4 - 1.9 OD | ||
30 | 00815686021122 | INS-5620 | INS-5620 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Kit | ||
31 | 00815686021061 | SFT-0004 | SFT-0004 | JAK | System, X-Ray, Tomography, Computed | 2 | ig4IR Software Application | |
32 | 00815686020439 | INS-0304 | INS-0304 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Trip Tracked Guidewire, 1.0mm, 735mm | |
33 | 00815686020392 | INS-0048 | INS-0048 | JAK | System, X-Ray, Tomography, Computed | 2 | vPad2 Connector Cable | |
34 | 00815686021252 | INS-5903 | INS-5903 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Adapter, Pentax | |
35 | 00815686021160 | INS-5901 | INS-5901 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Locking Device, Olympus | |
36 | 00815686020309 | INS-5029 | INS-5029 | JAK | System, X-Ray, Tomography, Computed | 19 UTW, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
37 | 00815686020255 | INS-5024 | INS-5024 | JAK | System, X-Ray, Tomography, Computed | 17ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
38 | 00815686020231 | INS-5022 | INS-5022 | JAK | System, X-Ray, Tomography, Computed | 17ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
39 | 00815686020651 | INS-5450 | INS-5450 | JAK | System, X-Ray, Tomography, Computed | SPiN Xtend 2.0mm OD, 21ga | ||
40 | 00815686020514 | INS-0342 | INS-0342 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked 20ga Aspiration Needle, 15mm L, 1.8mm OD | |
41 | 00815686021085 | SFT-0010 | SFT-0010 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiNPlanning Software Application | |
42 | 00815686020927 | INS-5035 | INS-5035 | JAK | System, X-Ray, Tomography, Computed | 17ga LG, 73mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
43 | 00815686021245 | INS-5902 | INS-5902 | JAK | System, X-Ray, Tomography, Computed | 2 | SPiN Access Catheter Adapter, Olympus 190 | |
44 | 00815686021207 | INS-5300 | INS-5300 | JAK | System, X-Ray, Tomography, Computed | 2 | Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm OD | |
45 | 00815686020217 | INS-5016 | INS-5016 | JAK | System, X-Ray, Tomography, Computed | 17ga, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
46 | 00815686020705 | INS-5040 | INS-5040 | JAK | System, X-Ray, Tomography, Computed | Always-On TIp Tracked Universal Tracker, LG, 7-12ga | ||
47 | 00815686020644 | INS-5440 | INS-5440 | JAK | System, X-Ray, Tomography, Computed | View Peripheral Catheter, 3.8mm OD, 2.5mm WC | ||
48 | 00815686021139 | INS-5610 | INS-5610 | JAK | System, X-Ray, Tomography, Computed | SPiN Perc Localization Needle 19ga x 105mm, 1cm marking zone | ||
49 | 00815686020286 | INS-5027 | INS-5027 | JAK | System, X-Ray, Tomography, Computed | 18ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point | ||
50 | 00815686020248 | INS-5023 | INS-5023 | JAK | System, X-Ray, Tomography, Computed | 17ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00811907031819 | LIA-01-001 | The Lung Image Analysis (LIA) software is designed to aid in the interpretation The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional.The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format. | Lung Image Analysis | PULMONX CORPORATION | |
2 | 00810040260001 | v1.0 | XR-29 Solution v1.0 | Z-DOSE29 | AGILITI HEALTH, INC. | |
3 | 00810030350095 | uMI 550 VM | The uMI 550 PET/CT is a diagnostic imaging system that combines two existing ima The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals. | uMI VM | UIH TECHNOLOGIES LLC | |
4 | 00810030350088 | uMI 550 | The uMI 550 PET/CT is a diagnostic imaging system that combines two existing ima The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals. | uMI | UIH TECHNOLOGIES LLC | |
5 | 00810030350040 | uCT 780 | The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular). | uCT | UIH TECHNOLOGIES LLC | |
6 | 00810030350033 | uCT 760 | The uCT Computed Tomography X-ray System uCT 760 is a computed tomography x-ray The uCT Computed Tomography X-ray System uCT 760 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular). | uCT | UIH TECHNOLOGIES LLC | |
7 | 00810030350026 | uCT 550 | The uCT Computed Tomography X-ray System uCT 550 is a computed tomography X-ray The uCT Computed Tomography X-ray System uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular. | uCT | UIH TECHNOLOGIES LLC | |
8 | 00810030350019 | uCT 530 | The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular. | uCT | UIH TECHNOLOGIES LLC | |
9 | 00195278592309 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | Omni | G E MEDICAL SYSTEMS ISRAEL LTD. | |
10 | 00195278469700 | Apex Select | B7919QT-B7919QS | Revolution Apex Select - Designated System Medical Device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
11 | 00195278454218 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | Omni | GE MEDICAL SYSTEMS, INC. | |
12 | 00195278403087 | Eagle | Revolution Eagle designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
13 | 00195278385215 | Advance | Revolution Advance designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
14 | 00195278363947 | 1.0 | MaxFOV 2 Application Container for Smart Subscription | MaxFOV 2 | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
15 | 00195278362247 | Frontier ES | Revolution Frontier ES for EOL CT Designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
16 | 00195278362230 | Frontier MDR | Revolution Frontier for EOL CT Designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
17 | 00195278303219 | 1.1 | MAR Application Container for Smart Subscription | MAR | GE HEALTHCARE JAPAN CORPORATION | |
18 | 00195278303202 | 1.1 | DLIR Application Container for Smart Subscription | DLIR | GE HEALTHCARE JAPAN CORPORATION | |
19 | 00195278303196 | 1.1 | ASiR-V Application Container for Smart Subscription | ASiR-V | GE HEALTHCARE JAPAN CORPORATION | |
20 | 00195278118295 | H3911AB | STARGATE NM GANTRY FINAL | StarGuide | G E MEDICAL SYSTEMS ISRAEL LTD. | |
21 | 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 | Discovery | GE MEDICAL SYSTEMS, INC. | |
22 | B887VC110030PL0 | VC-110-030-PL | VC-110-030-PL | 1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle. | VISICOIL | RADIOMED CORP |
23 | B887VC110020PL300 | 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 |
24 | B887VC110020PL0 | 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 |
25 | B887VC110010PL300 | 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 |
26 | B887VC110010PL0 | 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 |
27 | B887VC110005PL0 | 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 |
28 | B887VC075030PL0 | 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 |
29 | B887VC075020PL300 | 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 |
30 | B887VC075020PL120 | 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 |
31 | B887VC075020PL0 | 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 |
32 | B887VC075010PL300 | 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 |
33 | B887VC075010PL120 | 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 |
34 | B887VC075010PL0 | 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 |
35 | B887VC075005PL300 | 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 |
36 | B887VC075005PL120 | 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 |
37 | B887VC075005PL0 | 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 |
38 | B887VC050020PLSL0 | 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 |
39 | B887VC050020PL0 | VC-050-020-PL | VC-050-020-PL | 0.5mm x 2.0cm VISICOIL loaded in a 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
40 | B887VC050010PLSL0 | 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 |
41 | B887VC050010PL300 | 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 |
42 | B887VC050010PL0 | 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 |
43 | B887VC050005PLSL0 | 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 |
44 | B887VC050005PL300 | 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 |
45 | B887VC050005PL0 | 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 |
46 | B887VC035040PL0 | 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 |
47 | B887VC035030PL0 | 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 |
48 | B887VC035020PL0 | 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 |
49 | B887VC035010PL0 | 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 |
50 | B887VC035005PL0 | 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 |