No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M722XD20239B200370 | 1.2.0 | ClearRead Bone Suppress on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
2 | M722T18304V182920 | 3.3.3 | ClearRead CT | LLZ,OEB | System, Image Processing, Radiological,Lung Computed Tomography System, Computer System, Image Processing, Radiological,Lung Computed Tomography System, Computer-Aided Detection | 2 | ClearRead CT | |
3 | M722XD22145T212210 | 4.0.0 | ClearRead Compare on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Compare | |
4 | M722XD21224L212210 | 3.0.0 | ClearRead Confirm Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
5 | M722XD21224E212210 | 3.0.0 | ClearRead Enhance Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Enhance Docker | |
6 | M722XD21224C212210 | 6.1.0 | ClearRead Detect Docker | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
7 | M722XD21224B212210 | 4.0.0 | ClearRead Bone Suppress Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
8 | M722XD21012B203200 | 3.0.0 | ClearRead Bone Suppress on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
9 | M722XD20239C200370 | 1.2.0 | ClearRead Detect on Docker Platform | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
10 | M722XD20104C20370 | 5.3.1 | ClearRead Detect on Docker PlatformPrimary DI number should be M722XD20104C20037 ClearRead Detect on Docker PlatformPrimary DI number should be M722XD20104C200370.Re-entered 12/30/2020. | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
11 | M722XD20104C200370 | 1.1.0 | ClearRead Detect on Docker PlatformPrimary DI number mistyped as M722XD20104C203 ClearRead Detect on Docker PlatformPrimary DI number mistyped as M722XD20104C20370.Originally entered on 5/19/2020. | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
12 | M722XD20104B20370 | 3.6.2 | ClearRead Bone Suppress on Docker Platform.Primary DI Number should be M722XD201 ClearRead Bone Suppress on Docker Platform.Primary DI Number should be M722XD20104B200370.Re-entered 12/30/2020. | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
13 | M722XD20104B200370 | 1.1.0 | ClearRead Bone Suppress on Docker Platform.Primary DI Number mistyped as M722XD2 ClearRead Bone Suppress on Docker Platform.Primary DI Number mistyped as M722XD20104B20370.Originally entered on 5/19/2020 | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
14 | M722X21224E212210 | 3.0.0 | ClearRead Enhance on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Enhance Server | |
15 | M722X21165E211640 | 3.0.0 | ClearRead Enhance on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Enhance Server | |
16 | M722X21165C211640 | 6.1.0 | ClearRead Detect on Server | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Server | |
17 | M722X20320C203200 | 6.0.0 | ClearRead Xray +Detect on Connect Platform | MYN | Analyzer,Medical Image | 2 | ClearRead Xray +Detect | |
18 | M722R11266T00211 | 2.1 | Deltaview on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | Deltaview | |
19 | M722R11266C00521 | 5.2.1 | OnGuard on RCP Platform | MYN | Analyzer,Medical Image | 2 | OnGuard | |
20 | M722XD21165C211640 | 6.1.0 | ClearRead Detect Docker | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
21 | M722XD21165B211640 | 4.0.0 | ClearRead Bone Suppress Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
22 | M722XD21012C203200 | 3.0.0 | ClearRead Detect on Docker Platform | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
23 | M722X21224C212210 | 6.1.0 | ClearRead Detect on Server | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Server | |
24 | M722XC22145B212210 | 4.0.0 | ClearRead Bone Suppress on Console Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Bone Suppress | |
25 | M722XC21224L212210 | 3.0.0 | ClearRead Confirm Console | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Console | |
26 | M722XC21224C212210 | 6.1.0 | ClearRead Detect Console | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Console | |
27 | M722XC21165L211640 | 3.0.0 | ClearRead Confirm Console | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Console | |
28 | M722XC21165C211640 | 6.1.0 | ClearRead Detect Console | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Console | |
29 | M722X22145B212210 | 4.0.0 | ClearRead Bone Suppress on Server Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Bone Suppress | |
30 | M722X21224B212210 | 4.0.0 | ClearRead Bone Suppress on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Server | |
31 | M722X21165B211640 | 4.0.0 | ClearRead Bone Suppress on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Server | |
32 | M722X20320T203200 | 4.0.0 | ClearRead Xray +Compare on Connect Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray +Compare | |
33 | M722C22112V213240 | 5.5.0 | ClearRead CT Server | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Server | |
34 | M722C21343V213240 | 5.2.0 | ClearRead CT Server | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Server | |
35 | M722C21133V211240 | 5.0.0 | ClearRead CT Server | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Server | |
36 | M722C14295L142720 | 2.0 | ClearRead +Confirm on Connect Platform | LLZ | System, Image Processing, Radiological | 2 | Clear Read +Confirm | |
37 | M722XD22145B212210 | 4.0.0 | ClearRead Bone Suppress on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Bone Suppress | |
38 | M722XD21165L211640 | 3.0.0 | ClearRead Confirm Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
39 | M722Z19154V191210 | 1.0.2 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console | |
40 | M722XD20239L200370 | 1.2.0 | ClearRead Confirm on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
41 | M722XD20104L20370 | 2.2.1 | ClearRead Confirm on Docker PlatformPrimary DI Number should be M722XD20104L2003 ClearRead Confirm on Docker PlatformPrimary DI Number should be M722XD20104L200370.Re-entered on 12/30/2020. | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
42 | M722XD20104L200370 | 1.1.0 | ClearRead Confirm on Docker PlatformOriginally mistyped as M722XD20104L20370.Ori ClearRead Confirm on Docker PlatformOriginally mistyped as M722XD20104L20370.Originally entered on 5/19/2020. | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
43 | M722X21224T212210 | 4.0.0 | ClearRead Compare on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Compare Server | |
44 | M722X21165T211640 | 4.0.0 | ClearRead Compare on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Compare Server | |
45 | M722R14273T142720 | 3.1 | ClearRead +Compare on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead +Compare | |
46 | M722R14164T140290 | 3.1 | ClearRead +Compare on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead +Compare | |
47 | M722R14042T140290 | 3.1 | ClearRead +Compare on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead +Compare | |
48 | M722CC22110V213240 | 5.5.0 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console | |
49 | M722CC21343V213240 | 5.2.0 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console | |
50 | M722CC21133V211240 | 5.0.0 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00884838107540 | 795234 | EPIQ Elite Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
2 | 00884838107533 | 795232 | EPIQ CVxi Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
3 | 00884838107526 | 795231 | EPIQ CVx Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
4 | 00884838107519 | 795206 | EPIQ 5W Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
5 | 00884838107502 | 795204 | EPIQ 5 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
6 | 00884838107489 | 795202 | EPIQ 7W Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
7 | 00884838107465 | 795120 | EPIQ 5 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
8 | 00884838107458 | 795117 | EPIQ 7 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
9 | 00884838107441 | 795200 | EPIQ 7 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
10 | 00884838107069 | UroNav 4.1 | 784039 | UroNav | INVIVO CORPORATION | |
11 | 00884838106970 | 6 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
12 | 00884838106628 | 795218 | Affiniti 30 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
13 | 00884838106611 | 795210 | Affiniti 70 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
14 | 00884838106604 | 795208 | Affiniti 50 Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
15 | 00884838106598 | 795190 | Affiniti CVx Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
16 | 00884838106581 | 795121 | Affiniti 30 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
17 | 00884838106574 | 795119 | Affiniti 70 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
18 | 00884838106567 | 795118 | Affiniti 50 Diamond Select Ultrasound System | PHILIPS ULTRASOUND, INC. | ||
19 | 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. |
20 | 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. |
21 | 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 |
22 | 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. |
23 | 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. |
24 | 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. |
25 | 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. |
26 | 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. |
27 | 00884838100107 | 5 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
28 | 00884838099432 | 989606710361 | Percunav Planar Field Generator with Stand | PHILIPS ULTRASOUND, INC. | ||
29 | 00884838095250 | 4.2 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
30 | 00884838094857 | DynaCAD 5 | 4598-016-98182 | DynaCAD 5.0 | INVIVO | INVIVO CORPORATION |
31 | 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. |
32 | 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. |
33 | 00884838093072 | 4.1 | 98960612681X | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
34 | 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. |
35 | 00884838091818 | 459801572611 | UroNav Version 3 | Invivo | INVIVO CORPORATION | |
36 | 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. |
37 | 00884838091672 | 989605496481 | QLAB Advanced Quantification Software | PHILIPS ULTRASOUND, INC. | ||
38 | 00884838091429 | 3.2 | 98960612660X | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
39 | 00884838090736 | 989605492681 | QLAB Advanced Quantification Software | PHILIPS ULTRASOUND, INC. | ||
40 | 00884838090705 | 712035 | Stationary x-ray system | DigitalDiagnost C90 | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
41 | 00884838090699 | 712034 | Stationary x-ray system | DigitalDiagnost C90 | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
42 | 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. |
43 | 00884838089648 | 784026 | UroNav | Invivo | INVIVO CORPORATION | |
44 | 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. |
45 | 00884838087958 | v2.x | 45980141116X | 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. |
46 | 00884838087460 | 3.1 | 98960612483X | Cardiovascular Image and Information Management Solution (CVIS) | IntelliSpace Cardiovascular | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
47 | 00884838086777 | Dynamic Coronary Roadmap - 2 | 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. |
48 | 00884838086630 | 4.0 | Invivo | INVIVO CORPORATION | ||
49 | 00884838086623 | Release 3.8.5 | Q-Station | PHILIPS ULTRASOUND, INC. | ||
50 | 00884838086616 | Release 10.8.5 | QLAB Quantification Software | PHILIPS ULTRASOUND, INC. |