No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04260521365019 | 3.0 Galway | exoplan is a medical software, intended to support the pre-operative planning of exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides. | LLZ | System, Image Processing, Radiological | 2 | exoplan | |
2 | 04260521365002 | 2.3 Matera | exoplan is a medical software, intended to support the pre-operative planning of exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal.exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions.The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides. | LLZ | System, Image Processing, Radiological | 2 | exoplan | |
3 | 04260521363527 | 3.1 | The AbutmentCAD module is intended as an aid to the restoration of chewing funct The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device. | PNP | Dental Abutment Design Software For Dental Laboratory | 2 | AbutmentCAD | |
4 | 04260521363510 | 3.0 | The AbutmentCAD module is intended as an aid to the restoration of chewing funct The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandiblesand maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dentallaboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybridabutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturerof an endosseous dental implant abutment to create the final device. | PNP | Dental Abutment Design Software For Dental Laboratory | 2 | AbutmentCAD | |
5 | 04260521363305 | 1.0 | ChairsideCAD is a software device intended to support the design of dental resto ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings, veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is based on suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometrical output of the design for manufacturing on compatible CAM systems. ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose other than the design of dental restorations or bite splints, nor is it to be used for designing dental abutments. | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | Ceramill Mind DRS | |
6 | 04260521361509 | 2.3 (exoplan) | DentalDB is a software application intended for the management of data regarding DentalDB is a software application intended for the management of data regarding patients, cases, dental practices, dental laboratories, and manufacturing facilities. The optional dentalshare service allows for the transfer of pertinent data to and from remote facilities. DentalDB is intended for use by trained professionals, such as dental technicians and dentists. | OUG | Medical Device Data System | 1 | DentalDB | |
7 | 04260521361028 | 3.0 (ChairsideCAD) | DentalDB is a software application intended for the management of data regarding DentalDB is a software application intended for the management of data regarding patients, cases, dental practices, dental laboratories, and manufacturing facilities. The optional dentalshare service allows for the transfer of pertinent data to and from remote facilities. DentalDB is intended for use by trained professionals, such as dental technicians and dentists. | OUG | Medical Device Data System | 1 | DentalDB | |
8 | 04260521361011 | 2.3 (ChairsideCAD) | DentalDB is a software application intended for the management of data regarding DentalDB is a software application intended for the management of data regarding patients, cases, dental practices, dental laboratories, and manufacturing facilities. The optional dentalshare service allows for the transfer of pertinent data to and from remote facilities. DentalDB is intended for use by trained professionals, such as dental technicians and dentists. | OUG | Medical Device Data System | 1 | DentalDB | |
9 | 04260521361004 | 2.1 | DentalDB is a software application intended for the management of data regarding DentalDB is a software application intended for the management of data regarding patients, cases, dental practices, dentallaboratories, and manufacturing facilities. The optional dentalshare service allows for the transfer of pertinent data to andfrom remote facilities.DentalDB is intended for use by trained professionals, such as dental technicians and dentists. | OUG | Medical Device Data System | 1 | DentalDB | |
10 | 04260521363022 | 3.0 Galway | ChairsideCAD is a software device intended to support the design of dental resto ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings, veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is based on suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometrical output of the design for manufacturing on compatible CAM systems. ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose other than the design of dental restorations or bite splints, nor is it to be used for designing dental abutments. | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | ChairsideCAD | |
11 | 04260521363015 | 2.3 Matera | ChairsideCAD is a software device intended to support the design of dental resto ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings,veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is basedon suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometricaloutput of the design for manufacturing on compatible CAM systems.ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose otherthan the design of dental restorations or bite splints, nor is it to be used for designing dental abutments. | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | ChairsideCAD | |
12 | 04260521363008 | 2.1 | ChairsideCAD is a software device intended to support the design of dental resto ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings,veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is basedon suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometricaloutput of the design for manufacturing on compatible CAM systems.ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose otherthan the design of dental restorations or bite splints, nor is it to be used for designing dental abutments. | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | ChairsideCAD |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00093815716136 | 71613 | 71613 | Accessory Plug Type A & USB Cable Replacement Kit | FreeStyle | ABBOTT DIABETES CARE LTD |
2 | 00093815708452 | 70845 | 70845 | Abbott Diabetes Care USB Data Cable Software | Abbott | ABBOTT DIABETES CARE INC |
3 | 00093815000839 | 70845 | 70845 | Abbott Diabetes Care USB Data Cable Software | Abbott | ABBOTT DIABETES CARE INC |
4 | 00021292013622 | TRUE MANAGER AIR APP - Android | TRUE MANAGER AIR APP - Android | TRUE MANAGER AIR | TRIVIDIA HEALTH, INC. | |
5 | 00021292013196 | TRUE MANAGER AIR APP - Apple iOS | TRUE MANAGER AIR APP - Apple iOS | TRUE MANAGER AIR | TRIVIDIA HEALTH, INC. | |
6 | B595VMM2050 | VMM2050 Mobile Application | VMM2050 | The Vios Monitoring System (VMS) Mobile Application is indicated for use by heal The Vios Monitoring System (VMS) Mobile Application is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios mobile application receives and displays patient physiological and waveform data and alarms generated by Vios’ proprietary patient vitals monitoring software. The Vios Mobile Application is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. | Vios Monitoring System Mobile Application | MURATA VIOS PRIVATE LIMITED |
7 | B595VCS2050 | VCS2050 Software | VCS2050 | The Vios Monitoring System (VMS) Central Server (CS) Software acts as the server The Vios Monitoring System (VMS) Central Server (CS) Software acts as the server relay for the VMS system. It transmits, stores, and encrypts patient demographic and vitals data between multiple Vios BSMs to the Vios CSM. The Vios Central Server allows for retrieval of patient demographics, vitals and alarm data and product utilization through retrieval of audit logs. The Vios Central Server allows for creation and configuration of Monitoring Units (i.e. Wards), Caregivers, Departments, Rooms, Beds, and Default Monitoring Profiles for BSMs that are in Connected Mode.The Vios Central Station Monitor/Central Server Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios Central Station Monitor/Central Server SW receives, stores, manages and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software. | Vios Monitoring System Central Server | MURATA VIOS PRIVATE LIMITED |
8 | B595CSM20500 | CSM2050 Software | CSM2050 | The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software is indic The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios CSM SW receives, stores, manages, and displays patient physiological and waveform data, and alarms generated by Vios proprietary patient vitals monitoring software. The Vios CSM SW is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. | Vios Monitoring System Central Station Monitor | MURATA VIOS PRIVATE LIMITED |
9 | B334DBX1P40 | 1.4 | DBx | MIRADA MEDICAL LIMITED | ||
10 | B236VUE3000 | 3.0 | Sunquest VUE supports laboratories in the management of patient reports and to t Sunquest VUE supports laboratories in the management of patient reports and to transfer, store, and display test results and information. | Sunquest VUE | CLINISYS, INC | |
11 | B236SMG6300 | 6.3 | Sunquest Mitogen™ Genetics supports laboratories in the management of patient ge Sunquest Mitogen™ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information. | Sunquest Mitogen Genetics | CLINISYS, INC | |
12 | B236IX3200 | 3.2 | Sunquest Instrument Interfacing provides interfaces between laboratory instrumen Sunquest Instrument Interfacing provides interfaces between laboratory instruments and Sunquest products. | Sunquest Instrument Interfacing | CLINISYS, INC | |
13 | B236AI5300 | 5.3 | Sunquest Application Interface (AI) is to provide interfaces between client syst Sunquest Application Interface (AI) is to provide interfaces between client systems and Sunquest products to support laboratories in the management of laboratory workflow (order entry through reporting) and transfer test results and information | Sunquest Application Interfacing | CLINISYS, INC | |
14 | 60889978014576 | CS WinOMS | 8014573 | WinOMS Practice Management Software | CS WinOMS | CARESTREAM HEALTH, INC. |
15 | 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 |
16 | 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 |
17 | 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 |
18 | 15694311111153 | NOX-BTUNI_A | 544012 | Nox W7 Link Kit - A | NOX MEDICAL EHF. | |
19 | 15694311110637 | NOX-BTUNI_R | 544011 | Nox W7 Link Kit - R | NOX MEDICAL EHF. | |
20 | 15694311110620 | NOX-BTUNI_S | 544010 | Nox W7 Link Kit - S | NOX MEDICAL EHF. | |
21 | 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. | |
22 | 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. | |
23 | 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. | |
24 | 15099590684099 | V4.42MUA | 6000-0071 | LabPro Data Management System | MicroScan | BECKMAN COULTER, INC. |
25 | 15099590684082 | V4.42MUA | 6000-0070 | LabPro Data Management System | MicroScan | BECKMAN COULTER, INC. |
26 | 15099590684068 | V4.42MUA | LabPro Data Management System | MicroScan | BECKMAN COULTER, INC. | |
27 | 15099590676896 | V2.0 | LabPro-MBT System | MicroScan | BECKMAN COULTER, INC. | |
28 | 15099590676889 | V4.42 | LabPro Connect Data Management System | MicroScan | BECKMAN COULTER, INC. | |
29 | 15099590676872 | V4.42 | LabPro Data Management System | MicroScan | BECKMAN COULTER, INC. | |
30 | 15019517225495 | 22-4095-0206-25 | PharmGuard | SMITHS MEDICAL ASD, INC. | ||
31 | 15019517225488 | 22-0117-0203-25 | PharmGuard | SMITHS MEDICAL ASD, INC. | ||
32 | 10884521795150 | VDASHSUBEXS01 | Ventilation Dashboard v1.0 Excess Use Subscription | Vital Sync | COVIDIEN LP | |
33 | 10884521795143 | VDASHSUB01 | Ventilation Dashboard v1.0 Subscription | Vital Sync | COVIDIEN LP | |
34 | 10884521706675 | SBTWR v1.0 | Spontaneous Breathing Trial and Weaning Readiness Application v1.0 | Vital Sync | COVIDIEN LP | |
35 | 10884521706668 | EWS v1.0 | Early Warning Score Application v1.0 | Vital Sync | COVIDIEN LP | |
36 | 10841522125003 | 96190 | 1.X.X | XPREZZNET,96190 | Xprezznet | SPACELABS HEALTHCARE (WASHINGTON), INC |
37 | 10841522123658 | 92848 | 5.x.x | ENTERPRISE NETWORK INTERFACE,92848 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
38 | 10841522123641 | 92843 | 5.x.x | HL7 VITAL SIGNS INTERFACE,92843 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
39 | 10841522123634 | 92842 | 5.x.x | HL7,ADT INTERFACE,92842 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
40 | 10841522123610 | 92880 | 5.x.x | VITAL SIGNS VIEWER,92880 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
41 | 10841522123603 | 92877 | 5.x.x | 12 LEAD ECG INTERFACE,92877 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
42 | 10841522104558 | 94267 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | ||
43 | 10841522104541 | 94267 | XPREZZON and qube Display Options | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | |
44 | 10841522100192 | 96190 | 1.3.1 | Spacelabs Network Interface | Xprezznet | SPACELABS HEALTHCARE (WASHINGTON), INC |
45 | 10841522100178 | 92880 | V5.2.3 | VITAL SIGNS VIEWER,92880 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
46 | 10841522100161 | 92877 | V5.2.3 | 12 LEAD ECG INTERFACE,92877 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
47 | 10841522100154 | 92876 | V5.2.3 | CUSTOM TRENDS,92876 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
48 | 10841522100147 | 92848 | V5.2.3 | ENTERPRISE NETWORK INTERFACE,92848 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
49 | 10841522100130 | 92843 | V5.2.3 | HL7 VITAL SIGNS INTERFACE,92843 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
50 | 10841522100123 | 92842 | V5.2.3 | HL7,ADT INTERFACE,92842 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |