| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00763000138820 | 9732176 | KIT 9732176 TOUCH-N-GO | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 2 | 00763000053994 | 9734404 | AWL 9734404 TIP | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
| 3 | 00763000053895 | 9734296 | TAP 9734296 3.75 | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
| 4 | 00763000053819 | 9734402 | PROBE 9734402 LUMBAR | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
| 5 | 00763000053802 | 9734403 | PROBE 9734403 THORACIC | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
| 6 | 00763000052966 | 9732565 | Dilator, 9732565, 100mm | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 7 | 00643169843929 | 9735742 | SFW 9735742 STEALTH 3D ENT | PGW | Ear, Nose, and Throat Stereotaxic Instrument | 2 | NA | |
| 8 | 00885074314440 | 9731250 | PROBE 9731250 ENV CURVED SUCTION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 9 | 00885074549811 | 9732468 | INSERT 9732468 HIP NAVIGATION TRAY | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 10 | 00885074549781 | 9732664 | TRAY, 9732664, HIP NAVIGATION INSTR | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 11 | 00885074545066 | 9732389 | WRKSTN, 9732389, STEALTHSTATION INAV II | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 12 | 00885074530369 | 9732626 | PINS 9732626 FIXATOR 3IN AND 5IN | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 13 | 00885074517261 | 9732374XOM | INSTRUMENT 9732374XOM OSTIUM SEEKER ENV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 14 | 00885074515427 | 9732180 | CD, 9732180, LIBRARY - STEALTHLINK | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 15 | 00885074515410 | 9732178 | KIT, 9732178, STEALTHLINK | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 16 | 00885074511375 | 9732540 | SET 9732540 U ITHR INSTRUMENTS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 17 | 00885074511184 | 9732566 | ADAPTER 9732566 SHORT BED RAIL | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 18 | 00885074510484 | 9732463 | CD 9732463 INSTALL U ITHR INAV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 19 | 00885074498140 | 9660246 | ADAPTER, 9660246, PATIENT TRACKER RADIOL | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 20 | 00885074485058 | 9732576 | SFTWR 9732576 SECOND TOUCHSITE AUTOINS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 21 | 00885074447186 | 9732245 | FOOTSWITCH 9732245 WITH CABLE USB | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 22 | 00885074445465 | 9732430 | SOFTWARE, 9732430, SPINE UNIFIED | OLO,MAX | Orthopedic stereotaxic instrument,Intervertebral fusion device with bone graft, lumbar | 2 | N/A | |
| 23 | 00885074435558 | 9731958 | INSTALL DVD 9731958 SPINE TOOLSA^ | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
| 24 | 00885074416922 | 9732296 | PROBE 9732296 LONG POINTER 2.5 BALL | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 25 | 00885074403755 | 9732244 | SW 9732244 3D SPINE APPLICATION INAV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 26 | 00885074368856 | 9731883 | RACK 9731883 POLESTAR ASSY INT'L | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 27 | 00885074368825 | 9731873 | CART 9731873 POLESTAR NAVIGATION ASSY | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 28 | 00885074366722 | 9731838 | HARDWARE 9731838 POLESTAR INTEGRATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 29 | 00885074366715 | 9731839 | VIEW STATION 9731839 ASSEMBLED | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 30 | 00885074366661 | 9731844 | CART 9731844 POLESTAR VIEW STATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 31 | 00885074361505 | 9731909 | ROD, 9731909, DETACHABLE PRF | LNH | System, nuclear magnetic resonance imaging | 2 | N/A | |
| 32 | 00885074348827 | 9732236 | SPRING PADDLE 9732236 PASSIVE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 33 | 00885074338255 | 9732221 | DG KIT 9732221 SHORT DRILL GUIDE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 34 | 00885074328225 | 9732176 | KIT, 9732176, TOUCH-N-GO | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 35 | 00885074328195 | 9731965 | PROBE 9731965 BALL TIP ASSY - 4.3mm | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 36 | 00885074281179 | 9732010 | WORKSTATION 9732010 DBS TDS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 37 | 00885074262086 | 9731968 | TRAY, 9731968, ORTHONAV STERILIZATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 38 | 00885074240121 | 9731833 | DRIVER 9731833 1/4" BALL HEX | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 39 | 00885074240114 | 9731450 | HOLDER 9731450 MOBILE LOCALIZER | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 40 | 00885074240091 | 9731203 | FIELD GENERATOR 9731203 EM MOBILE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 41 | 00885074227337 | 9731808 | TRAY, 9731808 STERILIZATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 42 | 00885074203027 | 9731567XOM | ARRAY 9731567XOM SURETRAK2 ORANGE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 43 | 00885074102641 | 9731110 | HANDLE 9731110 IMAGE GUIDED | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 44 | 00885074140735 | 9731617 | MW 9731617 VM900 PTR ONLY INTF PLUS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 45 | 00885074129327 | 9731464 | BRACKET ADAPTER 9731464 MOLLER 20-1000 | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 46 | 00885074098685 | 9731581 | ACC 9731581 INST TRAY ASSY, INAV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 47 | 00885074098586 | 9731238 | WORKSTATION 9731238 50901CONFIG EU | HAW | Neurological stereotaxic Instrument | 2 | NA | |
| 48 | 00885074098579 | 9731217 | WORKSTATION 9731217 50901 CONFIGURED US | HAW | Neurological stereotaxic Instrument | 2 | NA | |
| 49 | 00885074079448 | 9732110 | SFTWR 9732110 FRAMELINK WORKSTATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
| 50 | 00885074079318 | 9731257 | WORKSTATION 9731257 DBS TDS UST | HAW | Neurological stereotaxic Instrument | 2 | N/A |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | EOLEOLEASPHEREV3P01 | 3.0 | Olea Sphere V3.0 is an image processing software package to be used by trained p Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | OLEA SPHERE | OLEA MEDICAL USA | |
| 2 | EOLEOLEASPHEREV2P31 | 2.3 | Olea Sphere V2.3 is an image processing software package to be used by trained p Olea Sphere V2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | OLEA SPHERE | OLEA MEDICAL USA | |
| 3 | EOLEFMRIV1P00 | V1.0 | Functional MR V1.0 is an optional image processing software application that is Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers.Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis.Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images. | FUNCTIONAL MR | OLEA MEDICAL USA | |
| 4 | EOLEBREASTSCAPEV1P00 | V1.0 | breastscape V1.0 is an optional image processing software application that is in breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists.breastscape V1.0 includes 2 software modules :- BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis.- BreastLoc to assist users in planning MR guided breast interventional procedures.Data and images are acquired through DICOM compliant imaging devices and modalities. | BREASTSCAPE | OLEA MEDICAL USA | |
| 5 | 04260361440204 | TTA2.51 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures andfunction based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to beused for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 6 | 04260361440198 | TTA2.42 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 7 | 04260361440181 | TTA2.50 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 8 | 04260361440174 | TTA2.41 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 9 | 04260361440167 | TTA2.40 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images.Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 10 | 04260361440150 | IA4 | The IMAGE-ARENA software platform is intended to import, export, store, retrieve The IMAGE-ARENA software platform is intended to import, export, store, retrieve and report digital studies. The IMAGE-ARENA software can import certain digital 2D or 3D image file formats of different modalities. IMAGE-ARENA offers a Generic Clinical Application Package interface in order to connect TOMTEC applications as well as commercially available analysis and quantification tools to the IMAGE-ARENA platform. It is intended as a general purpose digital medical image processing tool.IMAGE-ARENA is not intended to be used for reading of mammography images. | IMAGE-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 11 | 04260361440143 | TTA2 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 12 | 04251332920023 | 1.12 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 13 | 04251332920016 | 1.10 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 14 | 04251332920009 | 1.8.2 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 15 | 04251332910079 | 7.1.17 | Visage 7 | VISAGE IMAGING GMBH | ||
| 16 | 04251332910062 | 7.1.16 | Visage 7 | VISAGE IMAGING GMBH | ||
| 17 | 04251332910055 | 7.1.15 | Visage 7 | VISAGE IMAGING GMBH | ||
| 18 | 04251332910048 | 7.1.14 | Visage 7 | VISAGE IMAGING GMBH | ||
| 19 | 04251332910031 | 7.1.12 | Visage 7 | VISAGE IMAGING GMBH | ||
| 20 | 04251332910024 | 7.1.11 | Visage 7 | VISAGE IMAGING GMBH | ||
| 21 | 04251332910017 | 7.1.10 | Visage 7 | VISAGE IMAGING GMBH | ||
| 22 | 04251332910000 | 7.1.9 | Visage 7 | VISAGE IMAGING GMBH | ||
| 23 | 04250802900800 | 8.3 | DICOM picture archiving system | dicomPACS | OEHM UND REHBEIN GMBH | |
| 24 | 04250802900411 | 5 | SW1000 | Professional acquisition software for the connection and control of a direct rad Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide. | dicomPACS®DX-R | OEHM UND REHBEIN GMBH |
| 25 | 04250802900404 | 4.3 | SW1000 | Professional acquisition software for the connection and control of a direct rad Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide. | dicomPACS®DX-R | OEHM UND REHBEIN GMBH |
| 26 | 04056869955575 | 10400002 | MAMMOVISTA B.smart | SIEMENS HEALTHCARE GMBH | ||
| 27 | 04056869950181 | 11431561 | syngo.NM Organ Processing | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 28 | 04056869950174 | 11431560 | syngo.MI General | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 29 | 04056869950167 | 11431559 | syngo.MI Neurology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 30 | 04056869950150 | 11431558 | syngo.MI Cardiology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 31 | 04056869950143 | 11431557 | syngo.MM Oncology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 32 | 04056869296210 | 11583169 | syngo.MR Applications | SIEMENS HEALTHCARE GMBH | ||
| 33 | 04056869285801 | 11582847 | syngo.via | SIEMENS HEALTHCARE GMBH | ||
| 34 | 04056869281230 | 10400002 | MAMMOVISTA B.smart | SIEMENS HEALTHCARE GMBH | ||
| 35 | 04056869274621 | 11545288 | AI-Rad Companion Brain MR About Box | AI-Rad Companion Brain MR | SIEMENS HEALTHCARE GMBH | |
| 36 | 04056869272320 | 11552102 | syngo Dynamics VA20I Medical Device Identifier | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 37 | 04056869272313 | 11552103 | syngo Dynamics VA20I Packaging Label | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 38 | 04056869270142 | 11461768 | syngo.via View&GO (Version VA20A) | syngo.via View&GO (Version VA20A) | SIEMENS HEALTHCARE GMBH | |
| 39 | 04056869262567 | 11328180 | syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Applicat syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2 | syngo Application Software | SIEMENS HEALTHCARE GMBH | |
| 40 | 04056869259901 | 11551864 | syngo Dynamics VA20H Package Label | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 41 | 04056869259802 | 11461857 | syngo.via VB50A Medical Device Identifier | syngo.via | SIEMENS HEALTHCARE GMBH | |
| 42 | 04056869257945 | 11294429 | AI-Rad Companion Brain MR About Box | AI-Rad Companion Brain MR | SIEMENS HEALTHCARE GMBH | |
| 43 | 04056869257921 | 11294424 | AI-Rad Companion Engine product label | AI-Rad Companion Engine | SIEMENS HEALTHCARE GMBH | |
| 44 | 04056869256399 | 11551643 | syngo Dynamics VA20H | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 45 | 04056869253244 | 10745960 | syngo Dynamics VA40 Software | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 46 | 04056869251202 | 11270035 | AI-Rad Companion (Engine) | SIEMENS HEALTHCARE GMBH | ||
| 47 | 04056869248653 | 11327988 | syngo.Interventional VB40; Medical Device syngo.Interventional VB40 is covered b syngo.Interventional VB40; Medical Device syngo.Interventional VB40 is covered by NFJ to K190780 syngo Application Software VE20 | syngo.Interventional | SIEMENS HEALTHCARE GMBH | |
| 48 | 04056869247953 | 11368091 | syngo.via VB40A USB Media Virtual Container (Package) | syngo.via | SIEMENS HEALTHCARE GMBH | |
| 49 | 04056869247175 | 10745653 | syngo Dynamics VA20G Packaging Label | SIEMENS HEALTHCARE GMBH | ||
| 50 | 04056869247144 | 10745650 | syngo Dynamics VA20G | SIEMENS HEALTHCARE GMBH |