No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08800005200205 | eco-x-s | 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Pa 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, and oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions.In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis. | OAS | X-Ray, Tomography, Computed, Dental | 2 | eco-x series | |
2 | 08800005200199 | eco-x | 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Pa 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, and oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions.In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis. | OAS | X-Ray, Tomography, Computed, Dental | 2 | eco-x series | |
3 | 08800005200403 | DENTRI-Sα | The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIα series used by physicians, dentists, and x-ray technologists. | OAS | X-Ray, Tomography, Computed, Dental | 2 | DENTRIα series | |
4 | 08800005200397 | DENTRI-Cα | The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIα series used by physicians, dentists, and x-ray technologists. | OAS | X-Ray, Tomography, Computed, Dental | 2 | DENTRIα series | |
5 | 08800005200380 | DENTRIα | The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIα series used by physicians, dentists, and x-ray technologists. | OAS | X-Ray, Tomography, Computed, Dental | 2 | DENTRIα series | |
6 | 08800005200168 | WillCeph | WillCeph is intended for use by orthodontists, oral surgeons, and their clinical WillCeph is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images, including digitla photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions | LLZ | System, Image Processing, Radiological | 2 | WillCeph | |
7 | 08800005200151 | STAR-X | Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray im Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors. | EHD | Unit, X-Ray, Extraoral With Timer | 2 | STAR-X | |
8 | 08800005200045 | DENTRI-Sα | Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ra Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures. | OAS | X-Ray, Tomography, Computed, Dental | 2 | DENTRIα Series | |
9 | 08800005200038 | DENTRI-Cα | Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-r Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures. | OAS | X-Ray, Tomography, Computed, Dental | 2 | DENTRIα Series | |
10 | 08800005200021 | DENTRIα | Device Description: DENTRIα Series is a dental CT, panoramic X-ray system, whic Device Description: DENTRIα Series is a dental CT, panoramic X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures. | OAS | X-Ray, Tomography, Computed, Dental | 2 | DENTRIα Series | |
11 | 08800005200144 | Will3D | The Will3D is one of the components of a PACS (Picture Archiving and Communicati The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting. | LLZ | System, Image Processing, Radiological | 2 | Will3D | |
12 | 08800005200175 | Xcam | This X-ray Unit is intended to be used in portable applications, by a qualified/ This X-ray Unit is intended to be used in portable applications, by a qualified/trained dentist or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of dental structures. | EHD | Unit, X-Ray, Extraoral With Timer | 2 | Xcam | |
13 | 08800005200182 | Real Arch | Real Arch is a dental 3D scanner intended to be used to digitally record topogra Real Arch is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues.The Real Arch is composed of a hand-piece, power hub, adapter and usb3.0 cable. The system produces 3D scans for use in computer- assisted design and manufacturing of dental restorations. | 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 | Real Arch | |
14 | 08800005200434 | DENTRI-Sα | The DENTRI Max is a Computed Tomography X-Ray imaging device specialized in diag The DENTRI Max is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRI Max is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRI Max used by physicians, dentists, and x-ray technologists. | OAS | X-Ray, Tomography, Computed, Dental | 2 | DENTRI Max | |
15 | 08800005200427 | DENTRI-Cα | The DENTRI Max is a Computed Tomography X-Ray imaging device specialized in diag The DENTRI Max is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRI Max is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRI Max used by physicians, dentists, and x-ray technologists. | OAS | X-Ray, Tomography, Computed, Dental | 2 | DENTRI Max | |
16 | 08800005200410 | DENTRIα | The DENTRI Max is a Computed Tomography X-Ray imaging device specialized in diag The DENTRI Max is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRI Max is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRI Max used by physicians, dentists, and x-ray technologists. | OAS | X-Ray, Tomography, Computed, Dental | 2 | DENTRI Max | |
17 | 08800005200120 | DENTIOIII-S | The DENTIOIII-S is intended for dental radiographic examination of the teeth and The DENTIOIII-S is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists. | MUH | System, X-Ray, Extraoral Source, Digital | 2 | DENTIOIII series | |
18 | 08800005200113 | DENTIOIII | The DENTIOIII is intended for dental radiographic examination of the teeth and t The DENTIOIII is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic examinations. It is to be used only by dental practitioners and/or radiologists. | MUH | System, X-Ray, Extraoral Source, Digital | 2 | DENTIOIII series |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00885556805961 | ROB20025 | ROB20025 | RI.HIP MODELER | RI.HIP MODELER | SMITH & NEPHEW, INC. |
2 | 00885556604199 | 72204388 | 72204388 | DYONICS PLAN 1 YEAR SUBSCRIPTION 2 LICE | DYONICS | SMITH & NEPHEW, INC. |
3 | 00885556604182 | 72204387 | 72204387 | DYONICS PLAN 90DAY 2 LICENSES | DYONICS | SMITH & NEPHEW, INC. |
4 | 00885556604175 | 72204333 | 72204333 | DYONICS PLAN 1YEAR LICENSE | DYONICS | SMITH & NEPHEW, INC. |
5 | 00885556604168 | 72204332 | 72204332 | DYONICS PLAN 90DAY LICENSE | DYONICS | SMITH & NEPHEW, INC. |
6 | 00885556604151 | 72204331 | 72204331 | DYONICS PLAN SINGLE-USE TOKEN | DYONICS | SMITH & NEPHEW, INC. |
7 | 00884838107540 | 795234 | EPIQ Elite Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
8 | 00884838107533 | 795232 | EPIQ CVxi Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
9 | 00884838107526 | 795231 | EPIQ CVx Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
10 | 00884838107519 | 795206 | EPIQ 5W Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
11 | 00884838107502 | 795204 | EPIQ 5 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
12 | 00884838107489 | 795202 | EPIQ 7W Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
13 | 00884838107465 | 795120 | EPIQ 5 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
14 | 00884838107458 | 795117 | EPIQ 7 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
15 | 00884838107441 | 795200 | EPIQ 7 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
16 | 00884838107069 | UroNav 4.1 | 784039 | UroNav | INVIVO CORPORATION | |
17 | 00884838106970 | 6 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
18 | 00884838106628 | 795218 | Affiniti 30 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
19 | 00884838106611 | 795210 | Affiniti 70 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
20 | 00884838106604 | 795208 | Affiniti 50 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
21 | 00884838106598 | 795190 | Affiniti CVx Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
22 | 00884838106581 | 795121 | Affiniti 30 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
23 | 00884838106574 | 795119 | Affiniti 70 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
24 | 00884838106567 | 795118 | Affiniti 50 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
25 | 00884838104570 | ClarifEye - 1 | 002120 | Software medical device. Intended for use by professional healthcare providers a Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy. | ClarifEye | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
26 | 00884838103504 | 12 | 8986010 | The Vue PACS (Web Diagnostic) viewer is an add-on capability that allows running The Vue PACS (Web Diagnostic) viewer is an add-on capability that allows running the diagnostic viewer capabilities from a web browser. | Vue PACS (Web Diagnostic) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
27 | 00884838103450 | StentBoost Mobile | 718160 | StentBoost Mobile is a software product intended to provide a high resolution vi StentBoost Mobile is a software product intended to provide a high resolution visualization of stents in vessels. It supports the physician in placing and deploying stents. | StentBoost | PHILIPS INDIA LIMITED |
28 | 00884838101890 | StentBoost Live - 2 | 001017 | Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents. | StentBoost Live | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
29 | 00884838101883 | Dynamic Coronary Roadmap - 3 | 001016 | Software medical device, used with a Philips Interventional X-Ray System. Intend Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries. | Dynamic Coronary Roadmap | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
30 | 00884838100367 | 12 | 1017979 | The Vue Motion software program is used for patient management by clinicians in The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for diagnosis from different modalities including CR, DR, CT, MR, NM, ECG, and US. Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography. | Vue Motion | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
31 | 00884838100350 | 12 | 1149418 | The Vue PACS diagnostic client is web deployable and has a variety of user profi The Vue PACS diagnostic client is web deployable and has a variety of user profiles applicable to different stakeholder in the cycle of care such as radiologists, referring physicians, technologists etc. With advanced streaming technology, the Vue PACS diagnostic client can perform well even over slow communication lines between the client and the server. Enterprise workflow capabilities allow users across the network to read and report from a global worklist, irrespective of the image acquisition location. The Vue Diagnostic workstation includes native clinical applications such as Lesion Management, CT Perfusion, MR Perfusion/Diffusion. | Vue PACS (Diagnostic) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
32 | 00884838100336 | 12 | 8986424 | The Vue PACS is an image management system whose intended use is to provide comp The Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. The system is to be used by trained professionals including, but not limited to, physicians and medical technicians. | Vue PACS | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
33 | 00884838100107 | 5 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
34 | 00884838099432 | 989606710361 | Percunav Planar Field Generator with Stand | PHILIPS ULTRASOUND, INC. | ||
35 | 00884838095250 | 4.2 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
36 | 00884838094857 | DynaCAD 5 | 4598-016-98182 | DynaCAD 5.0 | INVIVO | INVIVO CORPORATION |
37 | 00884838093997 | v2.2 | 45980163324X | illumeo system is a software package used with general purpose computing hardwar illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context. | Illumeo | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
38 | 00884838093621 | 12.x | 45980163593X | IntelliSpace Portal is a software medical device that allows multiple users to r IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications. | IntelliSpace Portal | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
39 | 00884838093072 | 4.1 | 98960612681X | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
40 | 00884838091849 | 8.x | 837509 | Philips IntelliSpace Clinical Applications is an image processing workstation so Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images. | IntelliSpace Clinical Applications | PHILIPS HEALTHCARE INFORMATICS, INC. |
41 | 00884838091818 | 459801572611 | UroNav Version 3 | Invivo | INVIVO CORPORATION | |
42 | 00884838091740 | 4.x | 836344 | IntelliSpace Radiology Software (client) is a software package intended to be us IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using display monitors approved for digital mammography. | IntelliSpace Radiology | PHILIPS HEALTHCARE INFORMATICS, INC. |
43 | 00884838091672 | 989605496481 | QLAB Advanced Quantification Software | PHILIPS ULTRASOUND, INC. | ||
44 | 00884838091429 | 3.2 | 98960612660X | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
45 | 00884838090736 | 989605492681 | QLAB Advanced Quantification Software | PHILIPS ULTRASOUND, INC. | ||
46 | 00884838090705 | 712035 | Stationary x-ray system | DigitalDiagnost C90 | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
47 | 00884838090699 | 712034 | Stationary x-ray system | DigitalDiagnost C90 | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
48 | 00884838089808 | 11.x | 45980148092X | IntelliSpace Portal is a software medical device that allows multiple users to r IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications. | IntelliSpace Portal | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
49 | 00884838089648 | 784026 | UroNav | Invivo | INVIVO CORPORATION | |
50 | 00884838088566 | SmartPerfusion - 1 | 001119 | Software medical device used with a Philips Interventional X-Ray System. Provide Software medical device used with a Philips Interventional X-Ray System. Provides color coded representation of digital subtraction angiography to assist diagnosis of perfusion alterations of tissues. | SmartPerfusion | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |