No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850677007167 | 4.X | PACSgear Core Server | OUG | Medical Device Data System | 1 | PACSgear Core Server | |
2 | 00850677007341 | 3X | LLZ | System, Image Processing, Radiological | GearView Basic | |||
3 | 00850677007327 | 3X | LLZ | System, Image Processing, Radiological | 2 | GearView QC | ||
4 | 00850677007112 | 5 | PACS Scan Software CD | LLZ | System, Image Processing, Radiological | 2 | PACS Scan CD | |
5 | 00850677007211 | 3.X | Mod LInk | OUG | Medical Device Data System | 1 | PACSgear Mod Link | |
6 | 00850677007280 | 3.X | LMD | System, Digital Image Communications, Radiological | 1 | PACS Scan Web | ||
7 | 00850677007037 | 1 | Dicom Box Image Acquisition Unit | LMA | Digitizer, Image, Radiological | 2 | Dicom Box | |
8 | 00850677007006 | 5 | PACS Scan Software | LLZ | System, Image Processing, Radiological | 2 | PACS Scan | |
9 | 00850677007303 | 2.X | Encounter Manager | OUG | Medical Device Data System | 1 | Image Link Encounter Workflow | |
10 | 00850677007068 | MDR Video Cart | Cart for the MDR Video | LMA | Digitizer, Image, Radiological | 2 | MDR Video Cart | |
11 | 00850677007020 | 1 | MDR Video Image Acquisition | LMA | Digitizer, Image, Radiological | 2 | MDR Video | |
12 | 00850677007297 | 3.X | OUG | Medical Device Data System | 1 | Image Link | ||
13 | 00850677007266 | 3.X | OUG | Medical Device Data System | 1 | EHR-Gateway | ||
14 | 00850677007198 | 2.X | Image Link | OUG | Medical Device Data System | 1 | PACSgear Image Link | |
15 | 00850677007150 | 2.2.X | PSM2.2.2 | PACS Scan Mobile, Android | LMD | System, Digital Image Communications, Radiological | 1 | PACS Scan Mobile |
16 | 00850677007143 | 3.0 | PSM3.0 | The PACS Scan Mobile client is an application for mobile devices that can used t The PACS Scan Mobile client is an application for mobile devices that can used to easily capture images and videos and send them to patient studies on DICOM archives. The user queries and retrieves a patient study from a worklist, or creates a new patient record. The user may then take clinical photos and/or videos to send to the patient record. Photos may be manipulated (crop and rotate) and annotated prior to sending. Videos may not be altered prior to sending. Unwanted images may be deleted prior to sending. The user may also add a series description to the study. Typical users of the PACS Scan Mobile application are trained medical professionals, including but not limited to clinicians, technologists, assistants and lay persons. PSM is not intended for diagnostic use. | FXN,LMD | Tape, Camera, Surgical,System, Digital Image Communications, Radiological | 1 | PACS Scan Mobile |
17 | 00850677007235 | 2.X | EHR Gateway | OUG | Medical Device Data System | 1 | PACSgear EHR Gateway | |
18 | 00850677007228 | 3.X | Web Forms, Mod Link Web Forms | OUG | Medical Device Data System | 1 | PACSgear Web Forms | |
19 | 00850677007242 | 1.X | Media Writer Web | LMD | System, Digital Image Communications, Radiological | 1 | PACSgear Media Writer Web | |
20 | 00850677007181 | 2.X | PACS Scan Web | LMD | System, Digital Image Communications, Radiological | 1 | PACSgear PACS Scan Web | |
21 | 00850677007419 | 5.2.X | CS.5.2 | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use. | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server |
22 | 00850677007396 | 5.1.X | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includingpatient demographics, images, videos, and HL7 messages. It also handles user accounts, security, clientconfiguration, and the flow of data between modalities and destination DICOM systems. PACSgear | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server | |
23 | 00850677007389 | 1.X | Image Link Plus supports imaging workflows that do not follow the radiology work Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR). | OUG | Medical Device Data System | 1 | Image Link Plus | |
24 | 00850677007259 | 5.X | Core Server | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server | |
25 | 00850677007204 | 1.X | Image Link Encounter Workflow | OUG | Medical Device Data System | 1 | PACSgear Image Link Encounter Workflow | |
26 | 00850677007136 | 5 | Media Writer CD | LMD | System, Digital Image Communications, Radiological | 1 | Media Writer CD | |
27 | 00850677007082 | 2 | Video Touch 4K | LMA | Digitizer, Image, Radiological | 2 | MDR Video Touch | |
28 | 00850677007075 | MDR Video Speech | Speech for the MDR Video | LMA | Digitizer, Image, Radiological | 2 | MDR Video Speech | |
29 | 00850677007051 | 2 | Gearview QC Software | LLZ | System, Image Processing, Radiological | 2 | Gearview QC | |
30 | 00850677007273 | 4.X | Web Forms | OUG | Medical Device Data System | 1 | ModLink Web Forms | |
31 | 00850677007129 | 5 | Media Writer Software | LMD | System, Digital Image Communications, Radiological | 1 | Media Writer | |
32 | 00850677007105 | 2 | GEAR VIEW QC CD | LLZ | System, Image Processing, Radiological | 2 | GEAR VIEW QC CD |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10841522125003 | 96190 | 1.X.X | XPREZZNET,96190 | Xprezznet | SPACELABS HEALTHCARE (WASHINGTON), INC |
2 | 10841522123658 | 92848 | 5.x.x | ENTERPRISE NETWORK INTERFACE,92848 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
3 | 10841522123641 | 92843 | 5.x.x | HL7 VITAL SIGNS INTERFACE,92843 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
4 | 10841522123634 | 92842 | 5.x.x | HL7,ADT INTERFACE,92842 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
5 | 10841522123610 | 92880 | 5.x.x | VITAL SIGNS VIEWER,92880 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
6 | 10841522123603 | 92877 | 5.x.x | 12 LEAD ECG INTERFACE,92877 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
7 | 10841522104558 | 94267 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | ||
8 | 10841522104541 | 94267 | XPREZZON and qube Display Options | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | |
9 | 10841522100192 | 96190 | 1.3.1 | Spacelabs Network Interface | Xprezznet | SPACELABS HEALTHCARE (WASHINGTON), INC |
10 | 10841522100178 | 92880 | V5.2.3 | VITAL SIGNS VIEWER,92880 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
11 | 10841522100161 | 92877 | V5.2.3 | 12 LEAD ECG INTERFACE,92877 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
12 | 10841522100154 | 92876 | V5.2.3 | CUSTOM TRENDS,92876 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
13 | 10841522100147 | 92848 | V5.2.3 | ENTERPRISE NETWORK INTERFACE,92848 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
14 | 10841522100130 | 92843 | V5.2.3 | HL7 VITAL SIGNS INTERFACE,92843 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
15 | 10841522100123 | 92842 | V5.2.3 | HL7,ADT INTERFACE,92842 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
16 | M58802000780030 | DMS-100 | 020-007800-3 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Cinema MAS & MMS | STEREOTAXIS, INC. |
17 | M58800100790010 | Link | 001-007900-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey | STEREOTAXIS, INC. |
18 | M58800100784010 | Studio | 001-007840-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey Cinema | STEREOTAXIS, INC. |
19 | M58800100781010 | EIF | 001-007810-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey Enterprise Interface | STEREOTAXIS, INC. |
20 | 09420012424266 | 900ICON203 | 900ICON203 | F&P InfoUSB | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED |
21 | 09352527001192 | VFPROEX24.03 | ProEX Telehealth Hub System FSC2 - NTSC - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
22 | 09352527001185 | VFPROEX23.03 | ProEX Telehealth Hub System GEIS - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
23 | 09352527001161 | VFPROEX21.03 | ProEX Telehealth Hub System Standard - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
24 | 09352527000669 | VFPROEXMOBILE1.01 | ProEX Mobile Telehealth Hub | Visionflex | VISIONFLEX PTY. LTD. | |
25 | 09352527000614 | VFPROEX21.03 | ProEX Telehealth Hub System Standard - CLINICIAN v3 | Visionflex | VISIONFLEX PTY. LTD. | |
26 | 09352527000607 | VFPROEX26.02 | ProEX Telehealth Hub System FSC3 CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
27 | 09352527000591 | VFPROEX25.02 | ProEX Telehealth Hub System FSC2 CUSTOMER SUPPLIED - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
28 | 09352527000584 | VFPROEX24.02 | ProEX Telehealth Hub System FSC2 - NTSC - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
29 | 09352527000577 | VFPROEX23.02 | ProEX Telehealth Hub System GEIS - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
30 | 09352527000560 | VFPROEX22.02 | ProEX Telehealth Hub System FSC2 PAL - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
31 | 09352527000553 | VFPROEX21.02 | The ProEX Imaging Hub is specifically designed and engineered to enable health p The ProEX Imaging Hub is specifically designed and engineered to enable health practitioners all over the world to confidently carry out detailed medical examinations on patients based in regional, remote, rural and urban areas. | Visionflex | VISIONFLEX PTY. LTD. | |
32 | 09350855000214 | N05007 | RFID Medical Instrument tag | trophon AcuTrace Medical Instrument Tag | NANOSONICS LIMITED | |
33 | 09350855000207 | N05006 | RFID Operator card | trophon AcuTrace Operator Card | NANOSONICS LIMITED | |
34 | 08714729975700 | M00420020620 | M00420020620 | LABSYSTEM™ PRO EP Review Workstation Software | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION |
35 | 08714729884002 | M00420020300 | LABSYSTEM™ PRO EP Review Workstation Software, V2.7 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | |
36 | 08437014572308 | 1006 | KIRO Link is a software intended to store, convert formats, transfer and display KIRO Link is a software intended to store, convert formats, transfer and display the medical data required for the integration and workflow management functionalities of compounding associated technologies. These technologies include customer site software (Computerized Physician Order Entry (CPOE), logistics, quality control, etc.), Pharmacy Compounding Devices (PCDs) and compounding assisting software. The software is intended to be used only by qualified pharmacy personnel. | KIRO Link | KIRO GRIFOLS SL. | |
37 | 08052286590173 | EI KT0 0005 521 | Echolaser Smart Interface (ESI) and its accessories | Echolaser Smart Interface (ESI) | ELESTA SPA | |
38 | 08033737713037 | THD Procto Software | 760004 | The THD Procto Software System is a diagnostic system intended to be used to inv The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for:- Endoanal ultrasound (trans-rectal ultrasound / echography)- Anoscopy exams- Manometry exams | THD Procto Software System | THD SPA |
39 | 07613327505245 | 0101-2200 | 0101-2200 | Digital Port Connector | ADAPT | STRYKER LEIBINGER GMBH & CO. KG |
40 | 07613327482690 | 9222110000 | 9222-110-000 | System 9 Non-Sterile Battery, Small | N/A | STRYKER CORPORATION |
41 | 07613327482652 | 9126110000 | 9126-110-000 | System 9 Non-Sterile Battery, Large | N/A | STRYKER CORPORATION |
42 | 07613327467888 | 4608000000 | 4608-000-000 | System 9 Sagittal Saw | Sabo | STRYKER CORPORATION |
43 | 07613327467871 | 4605000000 | 4605-000-000 | System 9 Cordless Driver Handpiece | NA | STRYKER CORPORATION |
44 | 07613327467864 | 9209000000 | 9209-000-000 | System 9 Stryker Saw | Precision | STRYKER CORPORATION |
45 | 07613327467857 | 9208000000 | 9208-000-000 | System 9 Sagittal Saw | NA | STRYKER CORPORATION |
46 | 07613327467840 | 9207000000 | 9207-000-000 | System 9 Sternum Saw | NA | STRYKER CORPORATION |
47 | 07613327467833 | 9203000000 | 9203-000-000 | System 9 Single Trigger Rotary Handpiece | NA | STRYKER CORPORATION |
48 | 07613327467826 | 9206000000 | 9206-000-000 | System 9 Reciprocating Saw | NA | STRYKER CORPORATION |
49 | 07613327467819 | 9205000000 | 9205-000-000 | System 9 Dual Trigger Rotary Handpiece | NA | STRYKER CORPORATION |
50 | 07613327467765 | 9202000000 | 9202-000-000 | System 9 Saw | EZout | STRYKER CORPORATION |