| 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 | 04260521361516 | 3.0 (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 | 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 | |
| 8 | 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 | |
| 9 | 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 | |
| 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 | 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. | PACSgear Enterprise Server | HYLAND LLC |
| 2 | 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 | PACSgear Enterprise Server | HYLAND LLC | |
| 3 | 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). | Image Link Plus | HYLAND LLC | |
| 4 | 00850677007310 | 2.X | EHR-Gateway Print | HYLAND LLC | ||
| 5 | 00850677007303 | 2.X | Encounter Manager | Image Link Encounter Workflow | HYLAND LLC | |
| 6 | 00850677007297 | 3.X | Image Link | HYLAND LLC | ||
| 7 | 00850677007273 | 4.X | Web Forms | ModLink Web Forms | HYLAND LLC | |
| 8 | 00850677007266 | 3.X | EHR-Gateway | HYLAND LLC | ||
| 9 | 00850677007259 | 5.X | Core Server | PACSgear Enterprise Server | HYLAND LLC | |
| 10 | 00850677007235 | 2.X | EHR Gateway | PACSgear EHR Gateway | HYLAND LLC | |
| 11 | 00850677007228 | 3.X | Web Forms, Mod Link Web Forms | PACSgear Web Forms | HYLAND LLC | |
| 12 | 00850677007211 | 3.X | Mod LInk | PACSgear Mod Link | HYLAND LLC | |
| 13 | 00850677007204 | 1.X | Image Link Encounter Workflow | PACSgear Image Link Encounter Workflow | HYLAND LLC | |
| 14 | 00850677007198 | 2.X | Image Link | PACSgear Image Link | HYLAND LLC | |
| 15 | 00850677007167 | 4.X | PACSgear Core Server | PACSgear Core Server | HYLAND LLC | |
| 16 | 00850040853025 | Mobile RPM - Enterprise | Health Harmony Mobile is a component of the Health Harmony Remote Patient Monito Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The Enterprise version of Health Harmony Mobile is pre-loaded by the manufacturer on a personal mobile device that is provided to the patient in a Health Harmony Kit. | Health Harmony | CARE INNOVATIONS, LLC | |
| 17 | 00850040853018 | Mobile RPM - BYOD | Health Harmony Mobile is a component of the Health Harmony Remote Patient Monito Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The BYOD version of Health Harmony Mobile is available for download by the patient onto their own personal mobile device. | Health Harmony | CARE INNOVATIONS, LLC | |
| 18 | 00850031821026 | Nile for HCPs | A digital epilepsy care management web portal for HCP. | Nile HCP | AI NILE INC | |
| 19 | 00850031821019 | Nile for Android | A digital epilepsy care management platform application for Android. | Nile | AI NILE INC | |
| 20 | 00850031821002 | Nile for iOS | A digital epilepsy care management platform application for iOS. | Nile | AI NILE INC | |
| 21 | 00850015699016 | 43-5570-006-14 | After the surgery is completed, the OR Barcode Scanner can be used to scan the b After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components. | OR Barcode Scanner | CANARY MEDICAL USA LLC | |
| 22 | 00850010298061 | com.ekodevices.android.intl | Eko mobile app for android international platforms for use with Eko medical devices. | Eko Mobile App Android International | EKO DEVICES, INC. | |
| 23 | 00841709118319 | M9D-042 / 9A682001 | M9D-042-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 24 | 00841709118296 | M9-042 / 9A682001 | M9-042-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 25 | 00841709118289 | M9-041 / 9A682001 | M9-041-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 26 | 00841709118272 | M9-040 / 9A682001 | M9-040-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 27 | 00841709118241 | M11-042 / 9A682001 | M11-042-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 28 | 00841709118234 | M11-041 / 9A682001 | M11-041-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 29 | 00841709118227 | M11-040 / 9A682001 | M11-040-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 30 | 00841492104698 | 354018 | Responder | RAULAND-BORG CORPORATION | ||
| 31 | 00841492104681 | 354017 | Responder | RAULAND-BORG CORPORATION | ||
| 32 | 00841492104667 | 354016 | Responder | RAULAND-BORG CORPORATION | ||
| 33 | 00841492104643 | 354015 | Responder | RAULAND-BORG CORPORATION | ||
| 34 | 00841492104612 | 354012 | Responder | RAULAND-BORG CORPORATION | ||
| 35 | 00841492104582 | 354011 | Responder | RAULAND-BORG CORPORATION | ||
| 36 | 00841492104575 | 354010 | Responder | RAULAND-BORG CORPORATION | ||
| 37 | 00841492104568 | 354002 | Responder | RAULAND-BORG CORPORATION | ||
| 38 | 00841492104513 | 354001WP | Responder | RAULAND-BORG CORPORATION | ||
| 39 | 00841492104490 | 354001 | Responder | RAULAND-BORG CORPORATION | ||
| 40 | 00841492104476 | 354000 | Responder | RAULAND-BORG CORPORATION | ||
| 41 | 00841492104452 | 353200 | Responder | RAULAND-BORG CORPORATION | ||
| 42 | 00841492104445 | 353101 | Responder | RAULAND-BORG CORPORATION | ||
| 43 | 00841492104438 | 353100 | Responder | RAULAND-BORG CORPORATION | ||
| 44 | 00841492104421 | 353010 | Responder | RAULAND-BORG CORPORATION | ||
| 45 | 00841492104384 | 353001 | Responder | RAULAND-BORG CORPORATION | ||
| 46 | 00841492104360 | 353000 | Responder | RAULAND-BORG CORPORATION | ||
| 47 | 00841492104353 | 352021 | Responder | RAULAND-BORG CORPORATION | ||
| 48 | 00841492104339 | 352010 | Responder | RAULAND-BORG CORPORATION | ||
| 49 | 00841492104322 | 352004 | Responder | RAULAND-BORG CORPORATION | ||
| 50 | 00841492104308 | 352000 | Responder | RAULAND-BORG CORPORATION |