No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850376007635 | CP-NGS-SFA-MRDK | CP-NGS-SFA-MRDK | SMARTFrame Array MR Drilling Procedure Kit | HAW | Neurological Stereotaxic Instrument | 2 | Array |
2 | 00850376007628 | CP-NGS-SFA-MRBH | CP-NGS-SFA-MRBH | SMARTFrame Array MR Burr Hole Procedure Kit | HAW | Neurological Stereotaxic Instrument | 2 | Array |
3 | 00850376007611 | CP-NGS-SFA-ORMR | CP-NGS-SFA-ORMR | SMARTFrame Array OR-MR Procedure Kit | HAW | Neurological Stereotaxic Instrument | 2 | Array |
4 | 00850376007604 | NGS-SFA-03-2 | NGS-SFA-03-2 | SMARTFrame Array Kit, MR Drilling | HAW | Neurological Stereotaxic Instrument | 2 | Array |
5 | 00850359007904 | NGS-SFA-01-2 | NGS-SFA-01-2 | SMARTFrame Array Kit, OR-MRI | HAW | Neurological Stereotaxic Instrument | 2 | Array |
6 | 00850376007505 | CP-INHFF-232-01 | CP-INHFF-232-01 | Inflexion Head Fixation Frame fits IMRIS surgical tables | HBL | Holder, Head, Neurosurgical (Skull Clamp) | 2 | ClearPoint Inflexion IMRIS Head Fixation Frame |
7 | 00850359007843 | NGS-SF-02-11-7 | NGS-SF-02-11-7 | MRI Guided trajectory frame that is compatible with devices with ~ 7 Fr OD | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame XG-7 Fr |
8 | 00850359007829 | NGS-AK-01-11-7 | NGS-AK-01-11-7 | Clearpoint accessory kit that contains a 7 Fr Stylet and Lancet, and a peel awa Clearpoint accessory kit that contains a 7 Fr Stylet and Lancet, and a peel away sheath that accepts 7 Fr devices | HAW | Neurological Stereotaxic Instrument | 2 | ClearPoint 7 Fr Accessory Kit |
9 | 00850359007720 | MCA-66-250 | MCA-66-250 | MCA Kit, 6.6 mm OD x 250 mm Length | GWG | Endoscope, Neurological | 2 | ClearPoint PURSUIT |
10 | 00850359007713 | MCA-66-300 | MCA-66-300 | MCA Kit, 6.6 mm OD x 300 mm Length | GWG | Endoscope, Neurological | 2 | ClearPoint PURSUIT |
11 | 00850359007706 | MCA-59-250 | MCA-59-250 | MCA Kit, 5.9 mm OD x 250 mm Length | GWG | Endoscope, Neurological | 2 | ClearPoint PURSUIT |
12 | 00850359007690 | MCA-59-300 | MCA-59-300 | MCA Kit, 5.9 mm OD x 300 mm Length | GWG | Endoscope, Neurological | 2 | ClearPoint PURSUIT |
13 | 00850359007683 | MCA-53-250 | MCA-53-250 | MR Compatible Aspiration Kit, 5.3 mm OD x 250 mm Length | GWG | Endoscope, Neurological | 2 | ClearPoint PURSUIT |
14 | 00850359007676 | MCA-53-300 | MCA-53-300 | MR Compatible Aspiration Kit, 5.3 mm OD x 300 mm Length | GWG | Endoscope, Neurological | 2 | ClearPoint PURSUIT |
15 | 00850376007710 | NGS-SFA-DG-03 | NGS-SFA-DG-03 | SmartFrame® Array Offset & Center Guides, 5.4mm | HAW | Neurological Stereotaxic Instrument | 2 | SMARTFrame Array |
16 | 00850359007485 | NGS-NC-07 | NGS-NC-07 | Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 13mm tip | HCD | Cannula, Ventricular | 1 | Smartflow |
17 | 00850359007874 | NGS-XG-05 | NGS-XG-05 | A Device Guide used with SmartFrame XG that accepts ~6.0 mm drill bits | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame XG Exchangeable Drill Guide-6.0 mm |
18 | 00850359007294 | NGS-EC-16X24-06 | NGS-EC-16X24-06 | Flexible Self Adhesive Equipment Cover,16 x 24, 6 mil | ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri | 2 | MRII |
19 | 00850376007758 | NGS-SF-04-11 | NGS-SF-04-11 | SMARTFrame XG MRI-Guided Trajectory Frame w/o Base | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
20 | 00850376007598 | NGS-SFA-02-2 | NGS-SFA-02-2 | Array Kit with navigation frame, used mainly for burr hole procedures | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame Array |
21 | 00850359007959 | NGS-DB-45-S | NGS-DB-45-S | SmartTip MR Short Drill Bit Kit | HBG | Drills, Burrs, Trephines & Accessories (Manual) | 2 | SmartTip |
22 | 00850359007812 | NGS-AK-01-11-5 | NGS-AK-01-11-5 | An MRI Safe accessory kit with a 5 Fr stylet, lancet, and a peel away sheath tha An MRI Safe accessory kit with a 5 Fr stylet, lancet, and a peel away sheath that accepts ~5 Fr devices | HAW | Neurological Stereotaxic Instrument | 2 | ClearPoint 5 Fr Accessory Kit |
23 | 00850359007416 | NGS-RS-03 | NGS-RS-03 | SMARTFrame Scalp Mount Rescue Screw- Short | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
24 | 00850359007409 | NGS-RS-02 | NGS-RS-02 | SMARTFrame Scalp Mount Rescue Screw - Long | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
25 | 00850359007393 | NGS-RS-01 | NGS-RS-01 | SMARTFrame Skull Mount Rescue Screw | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
26 | 00850359007386 | NGS-CG-01 | NGS-CG-01 | SMARTFrame Wharen Centering Guide | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
27 | 00850359007362 | NGS-DB-45 | NGS-DB-45 | SmartTip MRII Drill Kit, 4.5 mm | HBG | Drills, Burrs, Trephines & Accessories (Manual) | 2 | SmartTip |
28 | 00850359007355 | NGS-DB-01 | NGS-DB-01 | SmartTip MRII Drill Kit, 3.2-mm | HBG | Drills, Burrs, Trephines & Accessories (Manual) | 2 | SmartTip |
29 | 00850359007331 | NGS-SK-01-11 | NGS-SK-01-11 | SmartFrame® Skull Mount Base | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
30 | 00850359007324 | NGS-SM-01 | NGS-SM-01 | SMARTFrame Scalp Mount Base | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
31 | 00850359007317 | NGS-XG-02 | NGS-XG-02 | SmartFrame® XG Exchangeable Device Guide, 4.5-mm | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
32 | 00850359007300 | NGS-XG-01 | NGS-XG-01 | SMARTFrame XG Exchangeable Device Guides | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
33 | 00850359007287 | NGS-GT-06 | NGS-GT-06 | SMARTFrame Guide Tubes .074” / 15 ga | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
34 | 00850359007270 | NGS-GT-05 | NGS-GT-05 | SMARTFrame Guide Tubes .068” / 16 ga | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
35 | 00850359007263 | NGS-GT-04 | NGS-GT-04 | SMARTFrame Guide Tubes .064” / CP Stylet | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
36 | 00850359007256 | NGS-GT-03 | NGS-GT-03 | SMARTFrame Guide Tubes .060” / 17 ga | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
37 | 00850359007249 | NGS-GT-02 | NGS-GT-02 | SMARTFrame Guide Tubes .052” / 18 ga | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
38 | 00850359007232 | NGS-GT-01 | NGS-GT-01 | SMARTFrame Guide Tubes | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
39 | 00850359007171 | NGS-TE-01 | NGS-TE-01 | SMARTFrame Thumb Wheel Extension Set | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
40 | 00850359007164 | NGS-HC-01 | NGS-HC-01 | SMARTFrame Hand Controller | ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri | 2 | SmartFrame |
41 | 00850359007157 | NGS-AK-01-11 | NGS-AK-01-11 | SMARTFrame Accessory Kit | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
42 | 00850359007133 | NGS-SF-03-11 | NGS-SF-03-11 | SMARTFrame MRI-Guided Trajectory Tower w/o Base | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
43 | 00850359007126 | NGS-SF-02-11 | NGS-SF-02-11 | SMARTFrame XG MRI-Guided Trajectory Frame | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
44 | 00850359007119 | NGS-SF-01-11 | NGS-SF-01-11 | SMARTFrame MRI-Guided Trajectory Frame | HAW | Neurological Stereotaxic Instrument | 2 | SmartFrame |
45 | 00850359007102 | CP-NGS-11-TE-CG45 | CP-NGS-11-TE-CG45 | SMARTFrame XG 4.5 w/ Wharen Centering Guide and TE | SmartFrame | |||
46 | 00850359007096 | CP-NGS-11-TE-TP45 | CP-NGS-11-TE-TP45 | SMARTFrame XG 4.5 TwistPoint Kit w/ TE | SmartFrame | |||
47 | 00850359007089 | CP-NGS-11-HC-TP45 | CP-NGS-11-HC-TP45 | SMARTFrame XG 4.5 TwistPoint Kit w/ HC | SmartFrame | |||
48 | 00850359007072 | CP-NGS-11-HC-TP32-E | CP-NGS-11-HC-TP32-E | SMARTFrame XG TwistPoint Kit w/ HC - E | SmartFrame | |||
49 | 00850359007058 | CP-NGS-11-HC-TP32 | CP-NGS-11-HC-TP32 | SMARTFrame XG TwistPoint Kit w/ HC | SmartFrame | |||
50 | 00850359007041 | CP-NGS-11-TE-SCM | CP-NGS-11-TE-SCM | SMARTFrame Scalp Mount Kit w/ TE | SmartFrame |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B973PREVIEWSHOULDER0 | 1.29.1 | PREVIEWSHOULDER | The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning s The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty. Preview Shoulder includes 3D digital representations of implants for placement in images used for surgical planning. Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users. The primary function of Preview Shoulder is to receive and process DICOM CT image(s) of patients. Preview Shoulder can be used to place an implant in the original CT image and place an implant in the 3D model of reconstructed bone. The Preview Shoulder allow the user to perform surgical planning and generate an output surgical report. Preview Shoulder does not provide a diagnosis or surgical recommendation. The surgeon is responsible for selecting and placing the implant model for pre-surgical planning purposes. | Preview | GENESIS SOFTWARE INNOVATIONS LLC |
2 | B664AMM60 | AMM6 | Arterys MICA | ARTERYS INC. | ||
3 | 17540262150018 | 1.0.0 | Change Healthcare Anatomical AI™ | CHANGE HEALTHCARE CANADA COMPANY | ||
4 | 07290019352037 | Lvivo_UI | Lvivo Standalone UI | DIA IMAGING ANALYSIS LTD | ||
5 | 07290019352020 | Lvivo_Seamless | Lvivo Seamless | DIA IMAGING ANALYSIS LTD | ||
6 | 07290019352013 | Lvivo_Mobile | Lvivo Mobile | DIA IMAGING ANALYSIS LTD | ||
7 | 07290019352006 | Lvivo_Platform | Lvivo Software Application Platform | DIA IMAGING ANALYSIS LTD | ||
8 | 06971576834143 | uWS-MR | uWS | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | ||
9 | 05060634690027 | Core 2.0 | EchoGo | ULTROMICS LIMITED | ||
10 | 05060634690003 | Core | EchoGo | ULTROMICS LIMITED | ||
11 | EOLEBREASTSCAPEV1P00 | V1.0 | breastscape V1.0 is an optional image processing software application that is in breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists.breastscape V1.0 includes 2 software modules :- BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis.- BreastLoc to assist users in planning MR guided breast interventional procedures.Data and images are acquired through DICOM compliant imaging devices and modalities. | BREASTSCAPE | OLEA MEDICAL USA | |
12 | 04260361440204 | TTA2.51 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures andfunction based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to beused for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
13 | 04260361440198 | TTA2.42 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
14 | 04260361440181 | TTA2.50 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
15 | 04260361440174 | TTA2.41 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
16 | 04260361440167 | TTA2.40 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images.Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
17 | 04251332930008 | 1.0 | Visage Breast Density | VISAGE IMAGING GMBH | ||
18 | 04056869950181 | 11431561 | syngo.NM Organ Processing | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
19 | 04056869950174 | 11431560 | syngo.MI General | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
20 | 04056869950167 | 11431559 | syngo.MI Neurology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
21 | 04056869950150 | 11431558 | syngo.MI Cardiology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
22 | 04056869950143 | 11431557 | syngo.MM Oncology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
23 | 04056869298207 | 11582982 | AI-Rad Companion Brain MR | SIEMENS HEALTHCARE GMBH | ||
24 | 04056869297279 | 11583323 | AI-Rad Companion (Pulmonary) | SIEMENS HEALTHCARE GMBH | ||
25 | 04056869274638 | 11545289 | AI-Rad Companion Prostate MR About Box | Ai-Rad Companion Prostate MR | SIEMENS HEALTHCARE GMBH | |
26 | 04056869257952 | 11294432 | AI-Rad Companion Prostate MR About Box | AI-Rad Companion Prostate MR | SIEMENS HEALTHCARE GMBH | |
27 | 00884838114470 | 795186 | Software Version 6.X | Affiniti 70C Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
28 | 00884838114463 | 795185 | Software Version 6.X | Affiniti 70W Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
29 | 00884838114456 | 795187 | Software Version 6.X | Affiniti 70 Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
30 | 00884838113961 | 795125 | Software Version 9.x | EPIQ Elite Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
31 | 00884838113923 | 795122 | Software Version 9.x | EPIQ CVx Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
32 | 00884838113916 | 795122 | Software version 7.x | EPIQ CVx Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
33 | 00884838113909 | 795121 | Software version 9.X | Affiniti 30 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
34 | 00884838113893 | 795121 | Software version 7.x | Affiniti 30 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
35 | 00884838113886 | 795120 | Software Version 9.X | EPIQ 5 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
36 | 00884838113862 | 795119 | Software version 9.X | Affiniti 70 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
37 | 00884838113855 | 795119 | Software version 7.x | Affiniti 70 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
38 | 00884838113848 | 795118 | 9.X | Affiniti 50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
39 | 00884838113831 | 795118 | Software Version 7.X | Affiniti 50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
40 | 00884838113824 | 795117 | Software Version 9.X | EPIQ 7 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
41 | 00884838113800 | 795116 | Software version 3.X | Sparq Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
42 | 00884838113794 | 795116 | Software version 2.X | Sparq Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
43 | 00884838113787 | 795114 | Software version 5.X | CX50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
44 | 00884838111004 | 795258 | Software version 6.X | EPIQ Elite W Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
45 | 00884838107540 | 795234 | EPIQ Elite Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
46 | 00884838107533 | 795232 | EPIQ CVxi Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
47 | 00884838107526 | 795231 | EPIQ CVx Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
48 | 00884838107519 | 795206 | EPIQ 5W Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
49 | 00884838107502 | 795204 | EPIQ 5 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
50 | 00884838107489 | 795202 | EPIQ 7W Ultrasound System | PHILIPS ULTRASOUND, INC. |