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 | 00850677007228 | 3.X | Web Forms, Mod Link Web Forms | OUG | Medical Device Data System | 1 | PACSgear Web Forms | |
18 | 00850677007310 | 2.X | OUG | Medical Device Data System | 1 | EHR-Gateway Print | ||
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 | J00714000630631 | 1400063 | 1400063 | iOptima consoles are control units designed to drive Bien-Air Dental SA's dental iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad). | iOptima APP | BIEN-AIR DENTAL SA |
2 | J00714000520521 | 1400052 | 1400052 | iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromo iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad). | iChiropro Surgery APP | BIEN-AIR DENTAL SA |
3 | J00714000510511 | 1400051 | 1400051 | iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromo iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad). | iChiropro APP | BIEN-AIR DENTAL SA |
4 | 07540196002394 | 01-111730 | 01-111730 | Data logger for Bravo Chamber Autoclave | Data Logger Bravo (T) | SCICAN LTD |
5 | 07540196002387 | 01-111729 | 01-111729 | Data logger for Bravo Chamber Autoclave | Data Logger Bravo (G) | SCICAN LTD |
6 | 07540196000963 | 01-111770 | 01-111770 | Data logger for Statim Cassette Autoclaves and Hydrim Instrument Washers | Data Logger Statim/Hydrim | SCICAN LTD |
7 | 07392532242380 | 75751 | 75751 | Navina Smart Transanal Irrigation. Bowel diary APP | Navina™ Smart App for Android | DENTSPLY IH AB |
8 | 07392532242373 | 75750 | 75750 | Navina Smart Transanal Irrigation. Bowel diary APP | Navina™ Smart App for iOS | DENTSPLY IH AB |
9 | 07350111070014 | 12000 | CoroFlow | COROVENTIS RESEARCH AB | ||
10 | 07350040976036 | CSS-0000NG | CSS-0000NG | The CellaVision Server Software is a network optimization design to create workf The CellaVision Server Software is a network optimization design to create workflow efficency in lager organizations and enables easy data transfer from all connected analyzers to a centralized database residing on a single server. | CellaVision® Server Softwaren, Upgrade to next generation | CELLAVISION AB |
11 | 07350040975961 | CSS-000099 | CSS-000099 | The CellaVision Server Software is a network optimization design to create workf The CellaVision Server Software is a network optimization design to create workflow efficency in lager organizations and enables easy data transfer from all connected analyzers to a centralized database residing on a single server. | CellaVision® Server Softwaren Non-expiring license | CELLAVISION AB |
12 | 07332747197136 | 3.13 | 300547 | DTX Studio Core 3.13 for Windows 64-bit | DTX Studio™ Core | NOBEL BIOCARE AB |
13 | 07332747187090 | 3.11 | 300547 | DTX Studio Core 3.11 for Windows 64-bit | DTX Studio™ Core | NOBEL BIOCARE AB |
14 | 07332747185102 | 3.10 | 300547 | DTX Studio Core 3.10 for Windows 64-bit | DTX Studio™ Core | NOBEL BIOCARE AB |
15 | 07332747180817 | 3.9 | 300547 | DTX Studio Core 3.9 for Windows 64-bit | DTX Studio™ Core | NOBEL BIOCARE AB |
16 | 07332747172874 | 3.8 | 300547 | DTX Studio Core 3.8 for Windows 64-bit | DTX Studio™ Core | NOBEL BIOCARE AB |
17 | 07332747166651 | 3.7 | 300547 | DTX Studio Core 3.7 for Windows 64-bit | DTX Studio™ Core | NOBEL BIOCARE AB |
18 | 07332699000751 | English | 8001027 | ICUpilot Software eng | M DIALYSIS INC. | |
19 | 07325710001806 | 6881603 | MSync | MAQUET CRITICAL CARE AB | ||
20 | 07290017735023 | 02.XX.YY | N/A | endo.digital platform is a software device that is designed to provide insulin t endo.digital platform is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG) and to patients with Type 2 diabetes on basal-bolus therapy via multiple daily injections (MDI), a continuous glucose monitoring (CGM) system and/or self-management blood glucose meter (SMBG). endo.digital gathers and analyses information inputted through the endo.digital Uploader or qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by endo.digital includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care. Following data collection and analysis, the endo.digital platform generates results containing summary data and recommendations for adjustments to the patient’s insulin therapy parameters, including a basal and bolus plan. endo.digital may also advise behavioral changes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patients. | endo.digital | DREAMED DIABETES LTD |
21 | 06948538362914 | WL-500 | WiFi Kit | / | BMC MEDICAL CO., LTD. | |
22 | 05060434420039 | QDMU | 3008-001-010 | Quantum Data Management Unit | Quantum ® | SPECTRUM MEDICAL LIMITED |
23 | 05060434420015 | VIPER DM | 3005-001-200 | Data Management Monitor | System M ® | SPECTRUM MEDICAL LIMITED |
24 | 05060229532794 | 5736-00 | Magstim Analytics | THE MAGSTIM COMPANY LIMITED | ||
25 | 05060229532725 | 5453-00 | Magstim Connect | THE MAGSTIM COMPANY LIMITED | ||
26 | 05056190500467 | Pole | SafeID | VISION RT LIMITED | ||
27 | 05056190500450 | SafeID Kiosk Box | SafeID | VISION RT LIMITED | ||
28 | 05056190500429 | SafeID Kiosk | SafeID | VISION RT LIMITED | ||
29 | 05056190500412 | SafeID Server WebAPI | SafeID | VISION RT LIMITED | ||
30 | 05056190500405 | SafeID 2.1 | SafeID | VISION RT LIMITED | ||
31 | 05056190500382 | SafeRT-ID (with interlock) | SafeRT-ID | VISION RT LIMITED | ||
32 | 05056190500375 | SafeRT-ID (no interlock) | SafeRT-ID | VISION RT LIMITED | ||
33 | 05056190500290 | Application Software | SafeRT-ID | VISION RT LIMITED | ||
34 | 05056190500283 | Server Software | SafeRT-ID | VISION RT LIMITED | ||
35 | 05021791987542 | 98754 | 98754 | FreeStyle Upload Cable | FreeStyle | ABBOTT DIABETES CARE LTD |
36 | 05021791000821 | 98754 | 98754 | FreeStyle Upload Cable | FreeStyle | ABBOTT DIABETES CARE LTD |
37 | 05020583940109 | 94010 | TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACE – Lite | TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACE | TERUMO BCT, INC. | |
38 | 04961333248025 | KBM68346 | ENDOPRO CAPTURE WORKSTATION, STANDALONE | ENDOPRO STANDALONEC CAPTURE WORKSTATION | PENTAX OF AMERICA, INC. | |
39 | 04961333248018 | KBM68345 | ENDOPRO CAPTURE WORKSTATION, NETWORK | ENDOPRO NETWORK CAPTURE WORKSTATION | PENTAX OF AMERICA, INC. | |
40 | 04961333248001 | KBM68344 | NA | ENDOPRO REVIEW WORKSTATION | ENDOPRO REVIEW WORKSTATION | PENTAX OF AMERICA, INC. |
41 | 04961333245314 | MSSQL-E8 | MS SQL ENT - 8 CORE LIC (RUNTIME) | N/A | PENTAX OF AMERICA, INC. | |
42 | 04961333245307 | MSSQL-E4 | MS SQL ENT - 4 CORE LIC (RUNTIME) | N/A | PENTAX OF AMERICA, INC. | |
43 | 04961333245291 | KBM68407 | STANDALONE IMAGE CAPTURE PC | N/A | PENTAX OF AMERICA, INC. | |
44 | 04961333245192 | 7190-5300 | MIC PRE-AMP KIT (ROLLS MP-13) | N/A | PENTAX OF AMERICA, INC. | |
45 | 04961333245161 | 7138 | SCAN CONVERTER | TV ONE | PENTAX OF AMERICA, INC. | |
46 | 04961333244706 | MSSQL-UM01A | MS SQL STD SINGLE USER LICENSE | N/A | PENTAX OF AMERICA, INC. | |
47 | 04961333244256 | PV-MVC/6 | CABLE, RGB W/SYNC 6FT. FOR EPK | N/A | PENTAX OF AMERICA, INC. | |
48 | 04961333244249 | PV-MVC/25 | CBL,4BNC-4BNC,25 VIDEO | N/A | PENTAX OF AMERICA, INC. | |
49 | 04961333244232 | PV-MVC/15 | CBL,4BNC-4BNC,15 VIDEO | N/A | PENTAX OF AMERICA, INC. | |
50 | 04961333244225 | PV-BBVC/6 | CBL,BNC-BNC,6 VIDEO | N/A | PENTAX OF AMERICA, INC. |