| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 03700757200803 | KIT0708 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his | HWT | Template | 1 | spineEOS rod Template |
| 2 | 03700757200797 | KIT0707 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 3 | 03700757200780 | KIT0706 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 4 | 03700757200773 | KIT0705 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 5 | 03700757200766 | KIT0704 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 6 | 03700757200759 | KIT0703 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 7 | 03700757200650 | KIT0702 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 8 | 03700757200643 | KIT0701 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 9 | 03700757200858 | 1.x | spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | LLZ | System, Image Processing, Radiological | 2 | spineEOS | |
| 10 | 03700757200544 | 1.1 | spineEOS allows surgeons to perform preoperative surgical planning of spine surg spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | LLZ | System, Image Processing, Radiological | 2 | spineEOS | |
| 11 | 03700757200834 | 3.x | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | LLZ | System, Image Processing, Radiological | 2 | hipEOS | |
| 12 | 03700757200520 | 2.5 | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | LLZ | System, Image Processing, Radiological | 2 | hipEOS | |
| 13 | 03700757200506 | 1.0 | kneeEOS allows surgeons to perform preoperative surgical planning of total kneea kneeEOS allows surgeons to perform preoperative surgical planning of total kneearthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg. | LLZ | System, Image Processing, Radiological | 2 | kneeEOS |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00842000101031 | 6.4 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 2 | 00842000101024 | 9.0 | Correcting entry. | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 3 | 00842000101017 | 8.2 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 4 | 00842000100980 | 8.1 | IBM iConnect Access 8.1 | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 5 | 00842000100935 | 8.2 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 6 | 00842000100928 | 12.1 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 7 | 00842000100881 | 6.3 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 8 | 00842000100867 | 4.3 | Standalone software application | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | |
| 9 | 00842000100850 | 4.3 | Standalone software application | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | |
| 10 | 00842000100843 | 7.2 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 11 | 00842000100829 | 13.0 | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 12 | 00842000100805 | 8.1 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 13 | 00842000100782 | 7.1 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 14 | 00842000100775 | 8.0 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 15 | 00842000100768 | 12.0.1 | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 16 | 00842000100751 | 11.1 | Merge Cardio V11.1 | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 17 | 00842000100744 | 12.0 | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 18 | 00842000100737 | 8.0 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 19 | 00842000100720 | 7.0 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 20 | 00842000100713 | 3.7.5 | Merge OrthoCase | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 21 | 00842000100706 | 7.3 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 22 | 00842000100690 | 7.3 | Merge PACS™ is a standards-based medical imaging diagnostic workstation that ser Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.). | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 23 | 00842000100683 | 6.5 | Stand alone software application. | iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 24 | 00842000100676 | 7.2 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 25 | 00842000100652 | 4.2.1 | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 26 | 00842000100645 | 6.4 | Software application that provides internet access to multi-modality softcopy me Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. | Merge iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 27 | 00842000100638 | 6.2 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 28 | 00842000100614 | 8.32 | RadSuite | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 29 | 00842000100607 | 7.1.0 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 30 | 00842000100591 | 10.1 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 31 | 00842000100577 | 7.0.2 | Standalone software application | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 32 | 00842000100560 | 7.0.2 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 33 | 00842000100508 | 6.6.3.2 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 34 | 00842000100478 | 7.1.2.1 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 35 | 00842000100461 | 11.0 | Merge Unity Pacs | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 36 | 00842000100454 | 7.1.2.1 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 37 | 00842000100416 | 11.0 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 38 | 00842000100409 | 7.2 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 39 | 00842000100348 | 6.6.3.2 | Standalone software application | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 40 | 00842000100331 | 11.2 | Standalone software application | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 41 | 00842000100300 | 4.2.1 | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 42 | 00842000100294 | 4.2 | Standalone software application | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | |
| 43 | 00842000100287 | 4.2 | Standalone software application | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | |
| 44 | 00842000100133 | 1.0 | Standalone software application. A universal workflow (non-medical tool) on Merg Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform. | iConnect Enterprise Workflow with Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 45 | 00842000100126 | 6.3 | Standalone software application. | Merge iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 46 | 00842000100089 | 7.1.1 | Standalone software application. | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 47 | 00842000100072 | 7.1.1 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 48 | 00842000100065 | 2.0 | Stand alone software application. | Merge Z3D | MERGE HEALTHCARE SOLUTIONS INC. | |
| 49 | 00842000100058 | 11.1.2 | Standalone software application | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 50 | 00842000100041 | 10.3 | Standalone software application. | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. |