No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00858012005922 | V3.4 | D70141, D70142, D70160 | "PowerLook Density Assessment 3.4 is a software application intended for use wit "PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid. | LLZ | System, Image Processing, Radiological | 2 | PowerLook Density Assessment V3.4 |
2 | 00858012005854 | V7.2 | DSC017-04-US | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | Powerlook PRO with SLD, GE, US |
3 | 00858012005748 | 720823 | F5410-30 | Packaged Cutout 30mm, xFlex | KPY | Shield, Protective, Personnel | 1 | Packaged Cutout 30mm, xFlex |
4 | 00858012005649 | 711110 | SK1050 | Surface Applicator Cone, 50mm | JAD | System, Therapeutic, X-Ray | 2 | Surface Applicator Cone, 50 mm |
5 | 00858012005601 | V7.2 | DSC017-01-US | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | PowerLook AMP PRO with SecondLook Digital |
6 | 00858012005496 | 720269 | AG3030 | Vaginal Applicator 30 mm | JAD | System, Therapeutic, X-Ray | 2 | Vaginal Applicator, 30mm |
7 | 00858012005410 | 720297 | SK3510 | Surface Applicator End Cap, 10 mm, 10-Pack | JAD | System, Therapeutic, X-Ray | 2 | (10) Applicator End Cap, 10 mm |
8 | 00858012005373 | 710707 | F5350-4 | Rigid Shield 4 cm | JAD | System, Therapeutic, X-Ray | 2 | Rigid Shield 4 cm |
9 | 00858012005342 | 720343 | AB2063E | Balloon Applicator, 5x7 cm Ellipsodial | JAD | System, Therapeutic, X-Ray | 2 | Balloon Applicator Kit |
10 | 00858012005335 | 720332 | AB2062 | Balloon Applicator, 5-6 cm Spherical | JAD | System, Therapeutic, X-Ray | 2 | Balloon Applicator Kit |
11 | 00858012005328 | 720331 | AB2061 | Balloon Applicator, 4-5 cm Spherical | JAD | System, Therapeutic, X-Ray | 2 | Balloon Applicator Kit |
12 | 00858012005311 | 720342 | AB2060 | Balloon Applicator, 3-4 cm Spherical | JAD | System, Therapeutic, X-Ray | 2 | Balloon Applicator Kit |
13 | 00858012005250 | V1.1 | DSC014-02-EU | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook PRO Tomo Detection and SLD, GE |
14 | 00858012005236 | V1.1 | DSC014-01-EU | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook PRO Tomo Detection and SLD, GE |
15 | 00858012005229 | V1.1 | DSC014-01-US | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook PRO Tomo Detection and SLD, GE |
16 | 00858012005205 | V2.1 | D70124, D70141 and D70126 | PowerLook Density Assessment is a software application intended for use with dig PowerLook Density Assessment is a software application intended for use with digital mammographysystems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue andtotal breast area estimates. PowerLook Density Assessment provides these numerical values for eachbreast as well as a density category to aid radiologists in the assessment of breast tissuecomposition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive ordiagnostic aid. | LLZ | System, Image Processing, Radiological | 2 | iReveal Breast Density Assessment |
17 | 00858012005168 | DSC010-08 | MYN | Analyzer, Medical Image | 2 | PowerLook AMP SLD Planmed | ||
18 | 00850008977237 | DSC018-07 | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook PRO+ 4GPU Tower Platform, US | ||
19 | 00850008977190 | DSC012-03 | LLZ | System, Image Processing, Radiological | 2 | PowerLook AMP with Density Assessment GE OUS | ||
20 | 00850008977084 | DSC011-03-US | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook 10 PRO+, Rack Mount, US | ||
21 | 00858012005960 | 2.1 | QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicio Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 2 | ProFound AI | ||
22 | 00858012005823 | V7.2 | DSC017-03-ROW | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | Powerlook PRO Hardware Upgrade, SLD |
23 | 00858012005809 | V7.2 | DSC017-02-ROW | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | Powerlook PRO Hardware Upgrade, SLD |
24 | 00858012005793 | V7.2 | DSC017-02-US | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | Powerlook PRO Hardware Upgrade, SLD |
25 | 00858012005588 | 720772 | F5201 | Flexishield Radiation Absorber, Box | KPY | Shield, Protective, Personnel | 1 | Flexishield Radiation Absorber |
26 | 00858012005694 | 720818 | F5410-15 | Packaged Cutout 15 mm, xFlex | KPY | Shield, Protective, Personnel | 1 | Packaged Cutout 15 mm, xFlex |
27 | 00858012005526 | 750850 | XP1200 | Axxent Surface Controller | JAD | System, Therapeutic, X-Ray | 2 | Axxent Surface Controller |
28 | 00858012005519 | 750050 | XP1100 | Axxent Standard Controller | JAD | System, Therapeutic, X-Ray | 2 | Axxent Standard Controller |
29 | 00858012005403 | 710710 | F5350-7 | Rigid Shield 7 cm | JAD | System, Therapeutic, X-Ray | 2 | Rigid Shield 7 cm |
30 | 00858012005304 | 720697 | S7551 | Axxent HDR X-Ray Source 50 cm HUT | JAD | System, Therapeutic, X-Ray | 2 | HDR X-ray Source 2.2 |
31 | 00858012005298 | 720684-02 | S7601 | Axxent HDR X-Ray Source 25 cm ESL | JAD | System, Therapeutic, X-Ray | 2 | HDR X-ray Source 2.2 |
32 | 00858012005281 | 720684 | S7501 | Axxent HDR X-Ray Source 25 cm HUT | JAD | System, Therapeutic, X-Ray | 2 | HDR X-ray Source 2.2 |
33 | 00858012005267 | V1.1 | D4D0181 | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook PRO Tomo Detection FRU |
34 | 00858012005243 | V1.1 | DSC014-02-US | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook PRO with Tomo Detection, Upgrade, GE |
35 | 00858012005175 | DSC010-09 | MYN | Analyzer, Medical Image | 2 | PowerLook AMP SLD Agfa CR | ||
36 | 00858012005113 | DSC010-03-EU | MYN | Analyzer, Medical Image | 2 | PowerLook AMP SLD Siemens OUS | ||
37 | 00850008977145 | DSC018-06 | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook PRO+ Rack-Mount, US | ||
38 | 00850008977244 | DSC018-07-UP | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook PRO+ 4GPU Tower Upgrade, US | ||
39 | 00850008977121 | DSC018-04 | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook PRO+ Hardware Platform GE, US | ||
40 | 00858012005939 | V2 | QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicio Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 2 | PowerLook Tomo Detection (ProFound AI) | ||
41 | 00858012005861 | V7.2 | D4D0192 | The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. | MYN | Analyzer,Medical Image | 2 | Powerlook PRO with SLD, FRU |
42 | 00858012005762 | 720825 | F5410-KIT | Packaged Cutout set,xFlex | KPY | Shield, Protective, Personnel | 1 | Packaged Cutout set,xFlex |
43 | 00858012005731 | 720822 | F5410-27 | Packaged Cutout 27 mm, xFlex | KPY | Shield, Protective, Personnel | 1 | Packaged Cutout 27 mm, xFlex |
44 | 00858012005717 | 720820 | F5410-22 | Packaged Cutout 22.2 mm, xFlex | KPY | Shield, Protective, Personnel | 1 | Packaged Cutout 22.2 mm, xFlex |
45 | 00858012005595 | 710339 | SK1000 | Surface Applicator Set | JAD | System, Therapeutic, X-Ray | 2 | Surface Applicator Set |
46 | 00858012005472 | 720267 | AG3020 | Vaginal Applicator 20 mm | JAD | System, Therapeutic, X-Ray | 2 | Vaginal Applicator, 20mm |
47 | 00858012005427 | 720298 | SK3520 | Surface Applicator End Cap, 20 mm, 10-Pack | JAD | System, Therapeutic, X-Ray | 2 | (10) Applicator End Cap, 20 mm |
48 | 00858012005274 | 710706 | F5350-3 | Rigid Shield 3 cm | JAD | System, Therapeutic, X-Ray | 2 | Rigid Shield 3 cm |
49 | 00858012005212 | V1.1 | DS0244, D70130 | The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images. | MYN | Analyzer,Medical Image | 2 | PowerLook Tomo Detection Software |
50 | 00858012005090 | DSC010-01-EU | MYN | Analyzer, Medical Image | 2 | PowerLook AMP SLD GE OUS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00817100020438 | OPALACQ-02-04-00-000 | Software, Opal Acquire Image Acquisition Software. | Konica Minolta Software Opal Acquire | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
2 | 00817100020421 | OPALACQ-02-03-04-000 | Software, Opal Acquire Image Acquisition Software | Konica Minolta Software Opal Acquire | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
3 | 00817100020414 | OPALACQ-04-01-00-000 | Software, Opal Acquire Image Acquisition Software. | Konica Minolta SW Opal (Acquire), 20/20 Opal (Acquire) | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
4 | 00817100020193 | EXA 01-04-000 | EXA is a software device that receives digital images and data from various sour EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.Lossy compressed mammographic images are not intended for diagnostic review. | Konica Minolta SW (PACS) Exa | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
5 | 00817100020186 | OPALACQ 04-02-01-000 | Software, Opal Acquire Image Acquisition Software. | Konica Minolta SW (Acquire) Opal, 20/20 Opal (Acquire) Vizion | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
6 | 00816847022606 | Fluoroscopic Insert | 351-80-11 | Single use stainless steel tube insert to be used for fluoroscopic feedback for Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cutting guides. | Vantage PSI | 3D SYSTEMS, INC. |
7 | 00816847022590 | Anatomical Model | 351-80-90 | A three dimensional physical model depicting patient specific anatomy. To be us A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. | Vantage PSI | 3D SYSTEMS, INC. |
8 | 00816847022583 | Tibia Cutting Guide | 351-80-10 | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | Vantage PSI | 3D SYSTEMS, INC. |
9 | 00816847022576 | Talus Cutting Guide | 351-80-00 | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | Vantage PSI | 3D SYSTEMS, INC. |
10 | 00816847022569 | 1.0.2 | The D2P software is a stand-alone modular software package that provides advance The D2P software is a stand-alone modular software package that provides advanced visualization of DICOM imaging data. This modular package includes, but is not limited to the following functions:- DICOM viewer and analysis- Automated segmentation- Editing and pre-printing- Seamless integration with 3D Systems printers- Seamless integration with 3D Systems software packages- Seamless integration with Virtual Reality visualization for non-diagnostic use | D2P | 3D SYSTEMS, INC. | |
11 | 00816847021470 | 1.0.2 | The D2P software is a stand-alone modular software package that allows easy to u The D2P software is a stand-alone modular software package that allows easy to use and quick digital 3D model preparation for printing or use by third party applications. The software is aimed at usage by medical staff, technicians, nurses, researchers or lab technicians that wish to create patient specific digital anatomical models for variety of uses such as training, education, and pre-operative surgical planning. The patient specific digital anatomical models may be further used as an input to a 3D printer to create physical models for visual, non-diagnostic use. This modular package includes, but is not limited to the following functions:- DICOM viewer and analysis- Automated segmentation- Editing and pre-printing- Seamless integration with 3D Systems printers- Seamless integration with 3D Systems software packages | D2P | 3D SYSTEMS, INC. | |
12 | 00816847021463 | Resected Anatomical Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
13 | 00816847021456 | Resected Full Skull Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
14 | 00816847021371 | 2.0.1. | PROcedure Rehearsal Studio | Image segmentation system for the transfer of imaging information from a medical Image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for surgical planning. | PROcedure Rehearsal Studio | 3D SYSTEMS, INC. |
15 | 00816847021364 | Metal Slot (45mm) | Reusable accessory Cutting insert | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
16 | 00816847021357 | Metal Slot (40mm) | Reusable accessory Cutting insert | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
17 | 00816847021340 | Metal Slot (35mm) | Reusable accessory Cutting insert | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
18 | 00816847021333 | Metal Slot (25mm) | Reusable accessory Cutting insert | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
19 | 00816847021326 | Drill Guide (1.1 mm & 2.3 mm Screws) | Reusable accessory drill guide | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
20 | 00816847021319 | Drill Guide (1mm Pre-Drill) | Reusable accessory drill guide | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
21 | 00816847021302 | Drill Guide (2.3 mm & 2.7 mm Screws) | Reusable accessory drill guide | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
22 | 00816847021296 | Drill Guide (2.0 mm Screws) | Reusable accessory drill guide | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
23 | 00816847021289 | Implant Template | A three dimensional physical model depicting patient specific anatomy. To be us A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
24 | 00816847021272 | Bone Graft Template | A three dimensional physical model depicting patient specific anatomy. To be us A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
25 | 00816847021265 | Graft Pre-Contouring Template | A three dimensional physical model depicting patient specific anatomy. To be us A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
26 | 00816847021258 | Resected Mandible Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
27 | 00816847021241 | Resected Maxilla Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
28 | 00816847021234 | Perfected Maxilla/Mandible 2-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
29 | 00816847021227 | Perfected Maxilla/Mandible 1-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
30 | 00816847021210 | Perfected Full Skull Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
31 | 00816847021203 | Perfected Mandible Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
32 | 00816847021197 | Perfected Maxilla Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
33 | 00816847021180 | Perfected Anatomical Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
34 | 00816847021173 | Mirrored Anatomical Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
35 | 00816847021166 | Repositioned Maxilla/Mandible 2-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
36 | 00816847021159 | Repositioned Maxilla/Mandible 1-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
37 | 00816847021142 | Repositioned Full Skull Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
38 | 00816847021135 | Repositioned Mandible Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
39 | 00816847021128 | Repositioned Maxilla Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
40 | 00816847021111 | Repositioned Anatomical Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
41 | 00816847021104 | Reconstructed Maxilla/Mandible 2-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
42 | 00816847021098 | Reconstructed Maxilla/Mandible 1-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
43 | 00816847021081 | Reconstructed Full Skull Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
44 | 00816847021074 | Reconstructed Mandible Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
45 | 00816847021067 | Reconstructed Maxilla Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
46 | 00816847021050 | Reconstructed Anatomical Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
47 | 00816847021043 | Maxilla/Mandible 2-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
48 | 00816847021036 | Maxilla/Mandible 1-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
49 | 00816847021029 | Full Skull Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
50 | 00816847021012 | Mandible Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. |