No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 60889978869848 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | 8869844 | 24X30CM CR MAMMO SCR EHR-M3 | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen |
2 | 60889978806324 | MIN-R 2 Cassette with MIN-R EV 190 Screen | 8806325 | 24X30CM MIN-R2 CASS W/EV 190 SCR | EAM,IXA | Screen, intensifying, radiographic,Cassette, radiographic film | 1 | MIN-R 2 Cassette with MIN-R EV 190 Screen |
3 | 60889978712878 | READYMATIC Fixer and Replenisher | 8712879 | READYMATIC Fixer and Repl - 4x1GL | IWZ | Film, radiographic | 1 | READYMATIC Fixer and Replenisher |
4 | 60889978622795 | CARESTREAM DRX-1 System | 8622797 | CARESTREAM DRX-1 SYSTEM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CARESTREAM DRX-1 System |
5 | 60889978621668 | Value Systems | 8621666 | GENERATOR GRP D 50KW 3P 208-240 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
6 | 60889978621651 | Value Systems | 8621658 | GENERATOR GRP C 50KW 3P 380-480 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
7 | 60889978615209 | DRX Plus 2530C Detector | 8615205 | DRX PLUS 2530C DETECTOR/ ASCEND | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DRX Plus 2530C Detector |
8 | 60889978611614 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8611618 | 24X30CM DV REPLCMT PLATE/EHR-M2 SCR | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
9 | 60889978607587 | 4343R Digital Image Receptor | 8607582 | GOS Scintillator 4343 CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | 4343R Digital Image Receptor |
10 | 60889978602773 | DRX-Evolution Plus System | 8602773 | FIBRE GRID DRX-EVO WALL 180CM10:1 40LPCM | KPR | System, x-ray, stationary | 2 | DRX-Evolution Plus System |
11 | 60889978463329 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8463325 | 18X24CM DV REPLCMT PLATE/EHR-M2 SCR | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
12 | 60889978359158 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8359150 | 24X30CM DVIEW CR MAMMO SCR EHR-M2 | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
13 | 60889978346134 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8346132 | 24X30CM DVIEW CR MAMMO SCR EHR-M | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
14 | 60889978344062 | X-OMAT MX Developer and Replenisher | 8344061 | X-OMAT MX Developer and Repl 10 GL | IWZ | Film, radiographic | 1 | X-OMAT MX Developer and Replenisher |
15 | 60889978215201 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen | 8215204 | 24X30 CR MAMMO CASS W/SNP-M1 SCREEN | MUE | Full field digital,system,x-ray,mammographic | 2 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen |
16 | 60889976701539 | Value Systems | 6701536 | GENERATOR GRP C 65KW 3P 380-480 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
17 | 60889976701522 | Value Systems | 6701528 | GENERATOR GRP C 80KW 3P 380-480 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
18 | 60889976701133 | TRIMAX 35C | 6701130 | TRIMAX 35C DETECTOR | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | TRIMAX 35C |
19 | 60889976579367 | Vita Flex CR System | 6579361 | VITA FLEX CR SYSTEM, NB 60PPH WITH PC&MO | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Vita Flex CR System |
20 | 60889976579343 | Vita Flex CR System | 6579346 | VITA FLEX CR SYSTEM 60PPH WITH PC&MONITO | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Vita Flex CR System |
21 | 60889976579336 | Vita Flex CR System | 6579338 | VITA FLEX CR SYSTEM 60PPH | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Vita Flex CR System |
22 | 60889976573785 | LINEAR MC 150 | 6573786 | R40-M-R MANUAL COLLIMATOR FOR DR | IZX | Collimator, manual, radiographic | 2 | LINEAR MC 150 |
23 | 60889976573631 | QW-420-T | 6573638 | QW-420-T MOTORIZED TILT WALL STAND RT | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
24 | 60889976573624 | QW-420-T | 6573620 | QW-420-T Motor Tilting Wall Stand (Left) | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
25 | 60889976573594 | QW-420-T | 6573596 | QW-420-MT Manual Tiltng WallStand (Left) | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
26 | 60889976573587 | QW-420-T | 6573588 | QW-420-MT Manual Tilting Wall Stand RT | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
27 | 60889976573525 | QT-730 | 6573521 | QT-730 RADIOGRAPHC ENCLOSED STYL TABLE | IZZ | Table, radiographic, non-tilting, powered | 2 | QT-730 |
28 | 60889976573235 | QG-40-3 | 6573232 | QG-400-3 QUEST GEN 32KW 3 PH 380-480 | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | QG-40-3 |
29 | 60889976567876 | CS 3500 3D Scanner Collar | 6567879 | CS3500 COLLAR PACKING (10 PIECES) | NOF | System, optical impression, computer assisted design and manufacturing (cad/cam) System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | CS 3500 3D Scanner Collar | |
30 | 60889976567166 | LINEAR MC 150 | 1015148 | R40-S-P PINNACLE MTRZD COLLIMATOR | IZX | Collimator, manual, radiographic | 2 | LINEAR MC 150 |
31 | 60889976567159 | LINEAR MC 150 | 1013309 | R40-M-P PROGENY MC150 MANUAL COLLIMATOR | IZX | Collimator, manual, radiographic | 2 | LINEAR MC 150 |
32 | 60889976566732 | CS 3500 3D Scanner Collar | 6566731 | CS3500 COLLAR PACKING (10 PIECES) | 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 | CS 3500 3D Scanner Collar |
33 | 60889976559857 | CS 1500 | 6559850 | CS1500 HAND PIECE WIRELESS | EIA | UNIT, OPERATIVE DENTAL | 1 | CS 1500 |
34 | 60889976559819 | CS 1500 | 6559819 | CS1500 INTRA ORAL CAMERA WIRED USB | EIA | UNIT, OPERATIVE DENTAL | 1 | CS 1500 |
35 | 60889976559802 | CS 1500 | 6559801 | CS1500 INTRA ORAL CAMERA WIRELESS | EIA | UNIT, OPERATIVE DENTAL | 1 | CS 1500 |
36 | 60889976041376 | Green X-ray Film WB | 6041370 | 25SH 14X36IN (FLAT) GREEN X-RAY WB | IWZ | Film, radiographic | Green X-ray Film WB | |
37 | 60889975950419 | DRX Plus 2530C Detector | AH9482 | PACKED, DETECTOR, 2530 C | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DRX Plus 2530C Detector |
38 | 60889975313580 | CS 8100 Access | 5313580 | CS 8100 ACCESS | MUH | System,x-ray,extraoral source,digital | 2 | CS 8100 Access |
39 | 60889975303062 | CS 8100 Access | 5303060 | CS 8100 ACCESS 110V 230V | MUH | System,x-ray,extraoral source,digital | 2 | CS 8100 Access |
40 | 60889975285931 | READYMATIC Fixer and Replenisher | 5285937 | READYMATIC FIXER AND REPL, 2X5L | IWZ | Film, radiographic | 1 | READYMATIC Fixer and Replenisher |
41 | 60889975284484 | X-OMAT LE+ Fixer and Replenisher | 5284484 | X-OMAT LE+ FIXER AND REPL 2X20L | IWZ | Film, radiographic | 1 | X-OMAT LE+ Fixer and Replenisher |
42 | 60889975211015 | CEPHALOSTAT | 5211016 | CEPH UPGRADE FOR 9X00 FAMILY | MUH,OAS | System,x-ray,extraoral source,digital,X-ray, tomography, computed, dental | 2 | CEPHALOSTAT |
43 | 60889975154237 | CG797 | 5154232 | SIZE A COLLIMAT. FOR I/O XRAY UNITS | EHD | UNIT, X-RAY, EXTRAORAL WITH TIMER | 2 | CG797 |
44 | 60889974160215 | DETECTOR,PACKED,TRIMAX,4343C | AE4205 | AY-DETECTOR, PACKED, 4343C, TRIMAX | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | TRIMAX 4343C Detector |
45 | 60889974007909 | CS 1600 | 9G1174 | Handpiece, Wired, 1600 | NBL | Laser,fluorescence caries detection | 2 | CS 1600 |
46 | 60889974007473 | 4343R Digital Image Receptor | 9G9998 | 43X43 GOS DETECTOR | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | 4343R Digital Image Receptor |
47 | 60889974007466 | 4343R Digital Image Receptor | 9G5716 | DRX-DETECTOR 43X43 CSI FIXED | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | 4343R Digital Image Receptor |
48 | 60889974001112 | QG-50-SE | 1015247 | QG-5000-4 ODYSSEY SE GEN 50KW | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | QG-50-SE |
49 | 60889974000979 | QG-40-3 | 1023290 | QG-40-3 X-RAY GEN 40KW 3 PHASE 380-480 | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | QG-40-3 |
50 | 60889974000696 | QW-420 | 1018811 | QW-420 VERTI-Q-VERTICAL WALLSTAND LEFT | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420 |
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. |