| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00863670000301 | Imorgon View/Workstation 2.7 | imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition com imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and reportinformation. | LLZ | System, Image Processing, Radiological | 2 | Imorgan Medical, LLC | |
| 2 | 00863670000349 | Imorgon Report Accelerator 1.4 | imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition com imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and reportinformation. | LLZ | System, Image Processing, Radiological | 2 | Imorgon Medical, LLC | |
| 3 | 00863670000325 | Imorgon Server 2.2 | imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition com imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and reportinformation. | LLZ | System, Image Processing, Radiological | 2 | Imorgon Medical, LLC | |
| 4 | 00863670000318 | Imorgon LaunchPad 2.5 | imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition com imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnosticworkstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and reportinformation. | LLZ | System, Image Processing, Radiological | 2 | Imorgon Medical, LLC |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00810007631103 | ZB-3D208 | ZB-3D208 | ANATOMICAL MODEL, RIB, SINGLE | AccuModel® | MEDCAD |
| 2 | 00810007631073 | ACS_GU | ACS_GU | ANATOMICAL MODEL, GUIDE | AccuModel | MEDCAD |
| 3 | 00810007630861 | ZB-3D108 | ZB-3D108 | ANATOMICAL MODEL, FIBULA | AccuModel® | MEDCAD |
| 4 | 00810007630854 | ZB-3D207 | ZB-3D207 | ANATOMICAL MODEL, SKULL AND MANDIBLE (FUSED) | AccuModel® | MEDCAD |
| 5 | 00810007630847 | ZB-3D206 | ZB-3D206 | ANATOMICAL MODEL, SKULL | AccuModel® | MEDCAD |
| 6 | 00810007630830 | ZB-3D204 | ZB-3D204 | ANATOMICAL MODEL, MANDIBLE AND MAXILLA | AccuModel® | MEDCAD |
| 7 | 00810007630823 | ZB-3D203 | ZB-3D203 | ANATOMICAL MODEL, MAXILLA | AccuModel® | MEDCAD |
| 8 | 00810007630816 | ZB-3D202 | ZB-3D202 | ANATOMICAL MODEL, MANDIBLE | AccuModel® | MEDCAD |
| 9 | 00810007630809 | ZB-3D102 | ZB-3D102 | ANATOMICAL MODEL, GRAFT | AccuModel® | MEDCAD |
| 10 | 00810007630793 | ZB-3D101 | ZB-3D101 | ANATOMICAL MODEL, IMPLANT MODEL | AccuModel® | MEDCAD |
| 11 | 00810007630786 | ZB-3D100 | ZB-3D100 | ANATOMICAL MODEL, HOST BONE PERI-DEFECT | AccuModel® | MEDCAD |
| 12 | 00810007630779 | ZB-3D-M | ZB-3D-M | ANATOMICAL MODEL, MISCELLANEOUS | AccuModel® | MEDCAD |
| 13 | 00810007630762 | ZB-K030 | ZB-K030 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ PLATE DESIGN | AccuPlan® System | MEDCAD |
| 14 | 00810007630755 | ZB-K021 | ZB-K021 | MIDFACE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan® System | MEDCAD |
| 15 | 00810007630748 | ZB-K020-R | ZB-K020-R | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan® System | MEDCAD |
| 16 | 00810007630731 | ZB-K020 | ZB-K020 | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan® System | MEDCAD |
| 17 | 00810007630724 | ZB-K011 | ZB-K011 | MANDIBLE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan® System | MEDCAD |
| 18 | 00810007630717 | ZB-K010-R | ZB-K010-R | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan® System | MEDCAD |
| 19 | 00810007630700 | ZB-K010 | ZB-K010 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan® System | MEDCAD |
| 20 | 00810007630694 | ZB-K004 | ZB-K004 | ORTHOGNATHIC, SURGICAL GUIDE | AccuPlan® System | MEDCAD |
| 21 | 00810007630687 | ZB-K003 | ZB-K003 | ORTHOGNATHIC, 3D PRINTED DENTAL MODELS | AccuPlan® System | MEDCAD |
| 22 | 00810007630670 | ZB-K002 | ZB-K002 | ORTHOGNATHIC, FINAL SPLINT | AccuPlan® System | MEDCAD |
| 23 | 00810007630663 | ZB-K001 | ZB-K001 | ORTHOGNATHIC, INTERMEDIATE SPLINT | AccuPlan® System | MEDCAD |
| 24 | 00810007630656 | ZB-K000-R | ZB-K000-R | ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT | AccuPlan® System | MEDCAD |
| 25 | 00810007630649 | ZB-K000 | ZB-K000 | ORTHOGNATHIC, SURGICAL PLANNING KIT | AccuPlan® System | MEDCAD |
| 26 | 00810007630533 | MC-K000-R | MC-K000-R | ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT | AccuPlan System | MEDCAD |
| 27 | 00810007630441 | MC-K020-R | MC-K020-R | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan System | MEDCAD |
| 28 | 00810007630427 | MC-K020 | MC-K020 | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan System | MEDCAD |
| 29 | 00810007630373 | MC-K021 | MC-K021 | MIDFACE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan System | MEDCAD |
| 30 | 00810007630366 | MC-K011 | MC-K011 | MANDIBLE RECONSTRUCTION, SURGICAL GUIDE | AccuPlan System | MEDCAD |
| 31 | 00810007630359 | MC-K010-R | MC-K010-R | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | AccuPlan System | MEDCAD |
| 32 | 00810007630342 | MC-K004 | MC-K004 | ORTHOGNATHIC, SURGICAL GUIDE | AccuPlan System | MEDCAD |
| 33 | 00810007630335 | MC-K010 | MC-K010 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT | AccuPlan System | MEDCAD |
| 34 | 00810007630328 | MC-K003 | MC-K003 | ORTHOGNATHIC, 3D PRINTED DENTAL MODELS | AccuPlan System | MEDCAD |
| 35 | 00810007630311 | MC-K002 | MC-K002 | ORTHOGNATHIC, FINAL SPLINT | AccuPlan System | MEDCAD |
| 36 | 00810007630304 | MC-K001 | MC-K001 | ORTHOGNATHIC, INTERMEDIATE SPLINT | AccuPlan System | MEDCAD |
| 37 | 00810007630298 | MC-K000 | MC-K000 | ORTHOGNATHIC, SURGICAL PLANNING KIT | AccuPlan System | MEDCAD |
| 38 | 00810007630281 | MC-3D207 | MC-3D207 | ANATOMICAL MODEL, SKULL AND MANDIBLE (FUSED) | AccuModel | MEDCAD |
| 39 | 00810007630274 | MC-3D206 | MC-3D206 | ANATOMICAL MODEL, SKULL | AccuModel | MEDCAD |
| 40 | 00810007630267 | MC-3D204 | MC-3D204 | ANATOMICAL MODEL, MANDIBLE AND MAXILLA | AccuModel | MEDCAD |
| 41 | 00810007630250 | MC-3D203 | MC-3D203 | ANATOMICAL MODEL, MAXILLA | AccuModel | MEDCAD |
| 42 | 00810007630243 | MC-3D202 | MC-3D202 | ANATOMICAL MODEL, MANDIBLE | AccuModel | MEDCAD |
| 43 | 00810007630236 | MC-3D109 | MC-3D109 | ANATOMICAL MODEL, GUIDE | AccuModel | MEDCAD |
| 44 | 00810007630229 | MC-3D108 | MC-3D108 | ANATOMICAL MODEL, FIBULA | AccuModel | MEDCAD |
| 45 | 00810007630212 | MC-3D101 | MC-3D101 | ANATOMICAL MODEL, IMPLANT MODEL | AccuModel | MEDCAD |
| 46 | 00810007630205 | MC-3D100 | MC-3D100 | ANATOMICAL MODEL, HOST BONE PERI-DEFECT | AccuModel | MEDCAD |
| 47 | 00810007630199 | MC-3D-M | MC-3D-M | ANATOMICAL MODEL, MISCELLANEOUS | AccuModel | MEDCAD |
| 48 | 00805736053661 | MD212G3 | NEC | NEC DISPLAY SOLUTIONS, LTD. | ||
| 49 | 00805736052923 | MD302C6 | NEC | NEC DISPLAY SOLUTIONS, LTD. | ||
| 50 | 00805736046250 | MD242C2 | NEC | NEC DISPLAY SOLUTIONS, LTD. |