| 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 | 00850677007310 | 2.X | OUG | Medical Device Data System | 1 | EHR-Gateway Print | ||
| 20 | 00850677007242 | 1.X | Media Writer Web | LMD | System, Digital Image Communications, Radiological | 1 | PACSgear Media Writer Web | |
| 21 | 00850677007181 | 2.X | PACS Scan Web | LMD | System, Digital Image Communications, Radiological | 1 | PACSgear PACS Scan Web | |
| 22 | 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 |
| 23 | 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 | |
| 24 | 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 | |
| 25 | 00850677007259 | 5.X | Core Server | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server | |
| 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 | 58051887042642 | THD HRStation | 800299 | THD HRStation is an integrated proctological station mainly dedicated to the dia THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions.Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound. | THD Procto Software System | THD SPA |
| 2 | 18033737712389 | THD Proctostation | 800198 | THD Proctostation is an integrated, modular and expandable one-stop platform for THD Proctostation is an integrated, modular and expandable one-stop platform for the Colo-Rectal Surgeon/Proctologist, to perform Anorectal manometry, EAUS and High Resolution Anoscopy. It includes:- THD Procto Software - proctology integrated software- Dedicated hardware composed of an All in One professional Personal Compuiter - Insulation Transformer - Procto Trolley with pivoting wheels, brakes and orientable dringging handle | THD Procto Software System | THD SPA |
| 3 | 18033737712341 | THD 4K CAM | 800195 | THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4 THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4K resolution using THD's diagnostic and surgical devices, equipped with a special mechanical connection interface and septic protection sleeve.Capture is done using the THD ProctoSoftware interface, a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera. | THD Procto Software System | THD SPA |
| 4 | 15694311111153 | NOX-BTUNI_A | 544012 | Nox W7 Link Kit - A | NOX MEDICAL EHF. | |
| 5 | 15694311110637 | NOX-BTUNI_R | 544011 | Nox W7 Link Kit - R | NOX MEDICAL EHF. | |
| 6 | 15694311110620 | NOX-BTUNI_S | 544010 | Nox W7 Link Kit - S | NOX MEDICAL EHF. | |
| 7 | 15099590733926 | V4.42 | DVD, LabPro V4.42 Panel Update-09 (US); LabPro V4.42 Panel Update-09 DVD Kit (US DVD, LabPro V4.42 Panel Update-09 (US); LabPro V4.42 Panel Update-09 DVD Kit (US); LabPro V4.42 System Kit w/Panel Update-09 (US) | MicroScan | BECKMAN COULTER, INC. | |
| 8 | 15099590731144 | V4.42 | DVD, LabPro V4.42 Panel Update-08 (US); LabPro V4.42 Panel Update-08 DVD Kit (US DVD, LabPro V4.42 Panel Update-08 (US); LabPro V4.42 Panel Update-08 DVD Kit (US); LabPro V4.42 System Kit w/Panel Update-08 (US) | MicroScan | BECKMAN COULTER, INC. | |
| 9 | 15099590703271 | V4.42 | CD, Labpro V4.42 Panel Update-07LabPro V4.42 Panel Update-07 Kit (US, OUS)LabPro CD, Labpro V4.42 Panel Update-07LabPro V4.42 Panel Update-07 Kit (US, OUS)LabPro V4.42 System Kit wPanel Update-07 (US,OUS) | MicroScan | BECKMAN COULTER, INC. | |
| 10 | 15099590684099 | V4.42MUA | 6000-0071 | LabPro Data Management System | MicroScan | BECKMAN COULTER, INC. |
| 11 | 15099590684082 | V4.42MUA | 6000-0070 | LabPro Data Management System | MicroScan | BECKMAN COULTER, INC. |
| 12 | 15099590684068 | V4.42MUA | LabPro Data Management System | MicroScan | BECKMAN COULTER, INC. | |
| 13 | 15099590676896 | V2.0 | LabPro-MBT System | MicroScan | BECKMAN COULTER, INC. | |
| 14 | 15099590676889 | V4.42 | LabPro Connect Data Management System | MicroScan | BECKMAN COULTER, INC. | |
| 15 | 15099590676872 | V4.42 | LabPro Data Management System | MicroScan | BECKMAN COULTER, INC. | |
| 16 | 15019517225495 | 22-4095-0206-25 | PharmGuard | SMITHS MEDICAL ASD, INC. | ||
| 17 | 15019517225488 | 22-0117-0203-25 | PharmGuard | SMITHS MEDICAL ASD, INC. | ||
| 18 | 10884521795150 | VDASHSUBEXS01 | Ventilation Dashboard v1.0 Excess Use Subscription | Vital Sync | COVIDIEN LP | |
| 19 | 10884521795143 | VDASHSUB01 | Ventilation Dashboard v1.0 Subscription | Vital Sync | COVIDIEN LP | |
| 20 | 10884521706675 | SBTWR v1.0 | Spontaneous Breathing Trial and Weaning Readiness Application v1.0 | Vital Sync | COVIDIEN LP | |
| 21 | 10884521706668 | EWS v1.0 | Early Warning Score Application v1.0 | Vital Sync | COVIDIEN LP | |
| 22 | 10841522125003 | 96190 | 1.X.X | XPREZZNET,96190 | Xprezznet | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 23 | 10841522123658 | 92848 | 5.x.x | ENTERPRISE NETWORK INTERFACE,92848 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 24 | 10841522123641 | 92843 | 5.x.x | HL7 VITAL SIGNS INTERFACE,92843 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 25 | 10841522123634 | 92842 | 5.x.x | HL7,ADT INTERFACE,92842 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 26 | 10841522123610 | 92880 | 5.x.x | VITAL SIGNS VIEWER,92880 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 27 | 10841522123603 | 92877 | 5.x.x | 12 LEAD ECG INTERFACE,92877 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 28 | 10841522104558 | 94267 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | ||
| 29 | 10841522104541 | 94267 | XPREZZON and qube Display Options | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | |
| 30 | 10841522100192 | 96190 | 1.3.1 | Spacelabs Network Interface | Xprezznet | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 31 | 10841522100178 | 92880 | V5.2.3 | VITAL SIGNS VIEWER,92880 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 32 | 10841522100161 | 92877 | V5.2.3 | 12 LEAD ECG INTERFACE,92877 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 33 | 10841522100154 | 92876 | V5.2.3 | CUSTOM TRENDS,92876 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 34 | 10841522100147 | 92848 | V5.2.3 | ENTERPRISE NETWORK INTERFACE,92848 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 35 | 10841522100130 | 92843 | V5.2.3 | HL7 VITAL SIGNS INTERFACE,92843 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 36 | 10841522100123 | 92842 | V5.2.3 | HL7,ADT INTERFACE,92842 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 37 | 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. |
| 38 | 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. |
| 39 | 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. |
| 40 | 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. |
| 41 | 09420012424266 | 900ICON203 | 900ICON203 | F&P InfoUSB | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED |
| 42 | 09352527001192 | VFPROEX24.03 | ProEX Telehealth Hub System FSC2 - NTSC - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 43 | 09352527001185 | VFPROEX23.03 | ProEX Telehealth Hub System GEIS - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 44 | 09352527001161 | VFPROEX21.03 | ProEX Telehealth Hub System Standard - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 45 | 09352527000669 | VFPROEXMOBILE1.01 | ProEX Mobile Telehealth Hub | Visionflex | VISIONFLEX PTY. LTD. | |
| 46 | 09352527000614 | VFPROEX21.03 | ProEX Telehealth Hub System Standard - CLINICIAN v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 47 | 09352527000607 | VFPROEX26.02 | ProEX Telehealth Hub System FSC3 CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 48 | 09352527000591 | VFPROEX25.02 | ProEX Telehealth Hub System FSC2 CUSTOMER SUPPLIED - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 49 | 09352527000584 | VFPROEX24.02 | ProEX Telehealth Hub System FSC2 - NTSC - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 50 | 09352527000577 | VFPROEX23.02 | ProEX Telehealth Hub System GEIS - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. |