| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B843UNISYN6110 | 6-1-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | LLZ | System, Image Processing, Radiological | 2 | UniSyn | |
| 2 | B843UNISYN5610 | 5-6-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | LLZ | System, Image Processing, Radiological | 2 | UniSyn | |
| 3 | B843UNISYN5510 | 5-5-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | LLZ | System, Image Processing, Radiological | 2 | UniSyn | |
| 4 | B843UNISYN5410 | 5-4-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | LLZ | System, Image Processing, Radiological | 2 | UniSyn | |
| 5 | B843UNISYN531P20 | 5-3-1-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | LLZ | System, Image Processing, Radiological | 2 | UniSyn | |
| 6 | B843UNISYN431P10 | 4-3-1-P1 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | LLZ | System, Image Processing, Radiological | 2 | UniSyn | |
| 7 | B843UNISYN425P20 | 4-2-5-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | LLZ | System, Image Processing, Radiological | 2 | UniSyn |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00721902966484 | 9731127 | SFTWR 9731127 KIT, STEALTHMERGE PLUS | FrameLink™ | MEDTRONIC NAVIGATION, INC. | |
| 2 | 00721902866074 | 9730903 | SFTWR 9730903 SFW, STEALTHMERGE PLUS | NA | MEDTRONIC NAVIGATION, INC. | |
| 3 | 00719192635272 | ASHK100G | LG | LG ELECTRONICS INC. | ||
| 4 | D800SY1620 | SY1620 | Rights of use Zirkonzahn.Implant-Planner Practice The conclusion of the Zirkonza Rights of use Zirkonzahn.Implant-Planner Practice The conclusion of the Zirkonzahn.Implant-Planner Practice service contract is obligatory for the duration of 12 months!Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner Practice | ZIRKONZAHN.Implant-Planner Practice | ZIRKONZAHN SRL | |
| 5 | D800SY1600 | SY1600 | Rights of use Zirkonzahn.Implant-Planner The conclusion of the Zirkonzahn.Implan Rights of use Zirkonzahn.Implant-Planner The conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for the duration of 12 months!Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner | ZIRKONZAHN.Implant-Planner | ZIRKONZAHN SRL | |
| 6 | D776SUITEV200 | V2.0 | SICAT SUITE | SICAT GMBH & CO. KG | ||
| 7 | D776SUITEV20 | V2.0 | SICAT SUITE | SICAT GMBH & CO. KG | ||
| 8 | D776IMPLANTV20400 | V2.0.40 | SICAT IMPLANT | SICAT GMBH & CO. KG | ||
| 9 | D776IMPLANTV200 | V2.0 | SICAT IMPLANT | SICAT GMBH & CO. KG | ||
| 10 | D776IMPLANTV150 | V1.5 | SICAT IMPLANT | SICAT GMBH & CO. KG | ||
| 11 | D776IMPLANTV15 | V1.5 | SICAT Implant | SICAT GMBH & CO. KG | ||
| 12 | D776GIV1920 | 1.9.2 | 6143205 | GALILEOS Implant | SICAT GMBH & CO. KG | |
| 13 | D776FUNCTIONV20400 | V2.0.40 | SICAT FUNCTION | SICAT GMBH & CO. KG | ||
| 14 | D776FUNCTIONV200 | V2.0 | SICAT FUNCTION | SICAT GMBH & CO. KG | ||
| 15 | D776FUNCTIONV20 | V2.0 | SICAT FUNCTION | SICAT GMBH & CO. KG | ||
| 16 | D776ENDOV20400 | V2.0.40 | SICAT ENDO | SICAT GMBH & CO. KG | ||
| 17 | D776ENDOV200 | V2.0 | SICAT ENDO | SICAT GMBH & CO. KG | ||
| 18 | D776ENDOV20 | V2.0 | SICAT ENDO | SICAT GMBH & CO. KG | ||
| 19 | D776AIRV20400 | 2.0.40 | SICAT Air | SICAT GMBH & CO. KG | ||
| 20 | D776AIRV200 | 2.0 | SICAT Air | SICAT GMBH & CO. KG | ||
| 21 | D77666224630 | 6622463 | 6622463 | Radiological Visualization Software for Diagnosis and Dental Treatment Planning | SICAT Endo | SICAT GMBH & CO. KG |
| 22 | D77664556410 | 6455641 | 6455641 | Radiological visualization software for diagnosis and dental treatment planning | SICAT Function | SICAT GMBH & CO. KG |
| 23 | D77664556330 | 6455633 | 6455633 | SICAT Suite | SICAT GMBH & CO. KG | |
| 24 | D74627314991 | 27-314-99 | 27-314-99 | VISTADENT® OC SUBSCRIPTION LAT AMERICA | VISTADENT® OC | RAINTREE ESSIX INC. |
| 25 | D74627313991 | 27-313-99 | 27-313-99 | VISTADENT® OC SUBSCRIPTION EAST | VISTADENT® OC | RAINTREE ESSIX INC. |
| 26 | D7462731199L1 | 27-311-99L | 27-311-99L | VISTADENT® OC COMPLETE LATIN AMERICA | VISTADENT® OC | RAINTREE ESSIX INC. |
| 27 | D7462731170L1 | 27-311-70L | 27-311-70L | VISTADENT® OC CONSULTANT (LATIN AM) | VISTADENT® OC | RAINTREE ESSIX INC. |
| 28 | D7462731099U1 | 27-310-99U | 27-310-99U | VISTADENT® OC COMPLETE UPDATE | VISTADENT® OC | RAINTREE ESSIX INC. |
| 29 | D74627310991 | 27-310-99 | 27-310-99 | VISTADENT® OC COMPLETE | VISTADENT® OC | RAINTREE ESSIX INC. |
| 30 | D7462731070U1 | 27-310-70U | 27-310-70U | VISTADENT® OC CONSULTANT UPDATE | VISTADENT® OC | DENTSPLY SIRONA ORTHODONTICS INC. |
| 31 | D74627310701 | 27-310-70 | 27-310-70 | VISTADENT® OC CONSULTANT | VISTADENT® OC | RAINTREE ESSIX INC. |
| 32 | 00697978970017 | NIL-READ-GLB | The NilRead software application provides desktop and portable access to multi-m The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography and breast tomosynthesis. NilRead also allows users to collaborate by sharing application sessions. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM “for presentation” images must be used.On mobile platforms, this device is not intended for diagnostic use. | NilRead | HYLAND SOFTWARE CANADA ULC | |
| 33 | 00685031000054 | 1 | A cloud-based, PACS-server software application that gives dental organizations A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device. | XVWeb | APTERYX INC | |
| 34 | 00685031000047 | 2 | A cloud-based, PACS-server software application that gives dental organizations A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device. | XVWeb | APTERYX INC | |
| 35 | 00685031000030 | 1 | Dental imaging capture, enhance and display software for XVWeb. | XVCapture | APTERYX INC | |
| 36 | 00685031000023 | 3 | Dental imaging capture, enhance and display software. | XrayVision DCV | APTERYX INC | |
| 37 | 00685031000016 | 3 | Dental imaging capture, enhance and display software. | XVlite | APTERYX INC | |
| 38 | 00685031000009 | 4 | Dental imaging capture, enhance and display software. | XrayVision | APTERYX INC | |
| 39 | 00670082000443 | 2.0 | SYN-0866 | Modus Plan | SYNAPTIVE MEDICAL INC | |
| 40 | 00670082000412 | 1.6 | SYN-0866 | BrightMatter Plan | SYNAPTIVE MEDICAL INC | |
| 41 | 00670082000368 | 1.5 | SYN-0004 | BrightMatter Plan | SYNAPTIVE MEDICAL INC | |
| 42 | 00670082000160 | 1.4 | SYN-0004 | BrightMatter Plan | SYNAPTIVE MEDICAL INC | |
| 43 | 00670082000139 | 13.1 | SYN-0524 | ClearCanvas Personal Edition Workstation | SYNAPTIVE MEDICAL INC | |
| 44 | 00670082000122 | 1.1 | SYN-0627 | ImageDrive Pro | SYNAPTIVE MEDICAL INC | |
| 45 | 00670082000115 | 1.1 | SYN-0578 | ImageDrive Clinical | SYNAPTIVE MEDICAL INC | |
| 46 | 00670082000085 | 1.3 | SYN-0004 | BrightMatter Plan | SYNAPTIVE MEDICAL INC | |
| 47 | 00667147001545 | V8 | PDDS | Polaroid DDS software | Polaroid DDS | SYNCA MARKETING INC |
| 48 | 00643169996182 | 9736048 | SFW KIT 9736048 STEALTHVIZ UPG | StealthViz | MEDTRONIC NAVIGATION, INC. | |
| 49 | 00643169941571 | 9735930 | SFW KIT 9735930 STEALTHVIZ S8 INT | StealthViz | MEDTRONIC NAVIGATION, INC. | |
| 50 | 00643169940765 | 9735913 | SFW 9735913 STEALTH S8 STEALTHVIZ APP | StealthViz | MEDTRONIC NAVIGATION, INC. |