No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00810007630762 | ZB-K030 | ZB-K030 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ PLATE DESIGN | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
2 | 00810007630755 | ZB-K021 | ZB-K021 | MIDFACE RECONSTRUCTION, SURGICAL GUIDE | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
3 | 00810007630748 | ZB-K020-R | ZB-K020-R | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
4 | 00810007630731 | ZB-K020 | ZB-K020 | MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
5 | 00810007630724 | ZB-K011 | ZB-K011 | MANDIBLE RECONSTRUCTION, SURGICAL GUIDE | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
6 | 00810007630717 | ZB-K010-R | ZB-K010-R | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
7 | 00810007630700 | ZB-K010 | ZB-K010 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
8 | 00810007630694 | ZB-K004 | ZB-K004 | ORTHOGNATHIC, SURGICAL GUIDE | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
9 | 00810007630687 | ZB-K003 | ZB-K003 | ORTHOGNATHIC, 3D PRINTED DENTAL MODELS | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
10 | 00810007630670 | ZB-K002 | ZB-K002 | ORTHOGNATHIC, FINAL SPLINT | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
11 | 00810007630663 | ZB-K001 | ZB-K001 | ORTHOGNATHIC, INTERMEDIATE SPLINT | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
12 | 00810007630656 | ZB-K000-R | ZB-K000-R | ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
13 | 00810007630649 | ZB-K000 | ZB-K000 | ORTHOGNATHIC, SURGICAL PLANNING KIT | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuPlan® System |
14 | 00810007631103 | ZB-3D208 | ZB-3D208 | ANATOMICAL MODEL, RIB, SINGLE | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuModel® |
15 | 00810007631097 | ZB-K036 | ZB-K036 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT BUNDLED W/ ACCUPLATE, NO GUIDES | JEY | Plate, Bone | 2 | AccuPlate |
16 | 00810007631080 | ZB-K035 | ZB-K035 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT BUNDLED W/ ACCUPLATE | JEY | Plate, Bone | 2 | AccuPlate |
17 | 00810007630793 | ZB-3D101 | ZB-3D101 | ANATOMICAL MODEL, IMPLANT MODEL | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuModel® |
18 | 00810007630861 | ZB-3D108 | ZB-3D108 | ANATOMICAL MODEL, FIBULA | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuModel® |
19 | 00810007630854 | ZB-3D207 | ZB-3D207 | ANATOMICAL MODEL, SKULL AND MANDIBLE (FUSED) | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuModel® |
20 | 00810007630847 | ZB-3D206 | ZB-3D206 | ANATOMICAL MODEL, SKULL | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuModel® |
21 | 00810007630830 | ZB-3D204 | ZB-3D204 | ANATOMICAL MODEL, MANDIBLE AND MAXILLA | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuModel® |
22 | 00810007630816 | ZB-3D202 | ZB-3D202 | ANATOMICAL MODEL, MANDIBLE | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuModel® |
23 | 00810007630809 | ZB-3D102 | ZB-3D102 | ANATOMICAL MODEL, GRAFT | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuModel® |
24 | 00810007630786 | ZB-3D100 | ZB-3D100 | ANATOMICAL MODEL, HOST BONE PERI-DEFECT | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuModel® |
25 | 00810007630779 | ZB-3D-M | ZB-3D-M | ANATOMICAL MODEL, MISCELLANEOUS | DZJ,LLZ | Driver, Wire, And Bone Drill, Manual,System, Image Processing, Radiological | 2 | AccuModel® |
26 | 00810007630588 | MC-K036 | MC-K036 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT BUNDLED WITH ACCUPLATE, NO GUIDES | JEY | Plate, Bone | 2 | AccuPlate |
27 | 00810007630571 | MC-PLT012 | MC-PLT012 | MANDIBLE, 2.6 FULL | JEY | Plate, Bone | 2 | AccuPlate |
28 | 00810007630564 | MC-PLT011 | MC-PLT011 | MANDIBLE, 2.6 DOUBLE ANGLE | JEY | Plate, Bone | 2 | AccuPlate |
29 | 00810007630557 | MC-PLT010 | MC-PLT010 | MANDIBLE, 2.6 HEMI | JEY | Plate, Bone | 2 | AccuPlate |
30 | 00810007630540 | MC-PLT009 | MC-PLT009 | MANDIBLE, 2.6 STRAIGHT | JEY | Plate, Bone | 2 | AccuPlate |
31 | 00810007630526 | MC-PLT008 | MC-PLT008 | MANDIBLE, 2.8 FULL | JEY | Plate, Bone | 2 | AccuPlate |
32 | 00810007630519 | MC-PLT007 | MC-PLT007 | MANDIBLE, 2.8 DOUBLE ANGLE | JEY | Plate, Bone | 2 | AccuPlate |
33 | 00810007630502 | MC-PLT006 | MC-PLT006 | MANDIBLE, 2.8 HEMI | JEY | Plate, Bone | 2 | AccuPlate |
34 | 00810007630496 | MC-PLT005 | MC-PLT005 | MANDIBLE, 2.8 STRAIGHT | JEY | Plate, Bone | 2 | AccuPlate |
35 | 00810007630489 | MC-PLT004 | MC-PLT004 | MANDIBLE, 2.0 FULL | JEY | Plate, Bone | 2 | AccuPlate |
36 | 00810007630472 | MC-PLT003 | MC-PLT003 | MANDIBLE, 2.0 DOUBLE ANGLE | JEY | Plate, Bone | 2 | AccuPlate |
37 | 00810007630465 | MC-PLT002 | MC-PLT002 | MANDIBLE, 2.0 HEMI | JEY | Plate, Bone | 2 | AccuPlate |
38 | 00810007630458 | MC-PLT001 | MC-PLT001 | MANDIBLE, 2.0 STRAIGHT | JEY | Plate, Bone | 2 | AccuPlate |
39 | 00810007630410 | MC-K035 | MC-K035 | MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE | JEY | Plate, Bone | 2 | AccuPlate |
40 | 00810007631042 | MC-AST20 | MC-AST20 | Titanium Cranial Implant, Medium | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | AccuShape® Titanium Patient-Specific Cranial Implant |
41 | 00810007631035 | MC-AST10 | MC-AST10 | Titanium Cranial Implant, Small | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | AccuShape® Titanium Patient-Specific Cranial Implant |
42 | 00810007631028 | ZB-AST40 | ZB-AST40 | Titanium Cranial Implant, Extra Large | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | AccuShape® Titanium Patient-Specific Cranial Implant |
43 | 00810007631011 | ZB-AST30 | ZB-AST30 | Titanium Cranial Implant, Large | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | AccuShape® Titanium Patient-Specific Cranial Implant |
44 | 00810007631004 | ZB-AST20 | ZB-AST20 | Titanium Cranial Implant, Medium | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | AccuShape® Titanium Patient-Specific Cranial Implant |
45 | 00810007630984 | ZB-PLT012 | ZB-PLT012 | MANDIBLE, 2.6 FULL | JEY | Plate, Bone | 2 | AccuPlate® Patient-Specific Plate |
46 | 00810007630977 | ZB-PLT011 | ZB-PLT011 | MANDIBLE, 2.6 DOUBLE ANGLE | JEY | Plate, Bone | 2 | AccuPlate® Patient-Specific Plate |
47 | 00810007630960 | ZB-PLT010 | ZB-PLT010 | MANDIBLE, 2.6 HEMI | JEY | Plate, Bone | 2 | AccuPlate® Patient-Specific Plate |
48 | 00810007630953 | ZB-PLT009 | ZB-PLT009 | MANDIBLE, 2.6 STRAIGHT | JEY | Plate, Bone | 2 | AccuPlate® Patient-Specific Plate |
49 | 00810007630946 | ZB-PLT008 | ZB-PLT008 | MANDIBLE, 2.8 FULL | JEY | Plate, Bone | 2 | AccuPlate® Patient-Specific Plate |
50 | 00810007630939 | ZB-PLT007 | ZB-PLT007 | MANDIBLE, 2.8 DOUBLE ANGLE | JEY | Plate, Bone | 2 | AccuPlate® Patient-Specific Plate |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B269SWR00069MD0 | SWR-00069-MD | CuattroDR System Software | CuattroDR | CUATTRO MEDICAL | |
2 | B269SWR00021MD0 | SWR-00021-MD | CloudDR™ Medical System Software | CloudDR™ | CUATTRO MEDICAL | |
3 | B229S210011 | 1 | System 2100 | MATH RESOLUTIONS, LLC | ||
4 | B228INTELEPACS0 | INTELEPACS | INTELEPACS | LES SYSTÈMES MÉDICAUX INTELERAD INCORPORÉE | ||
5 | B209XP2X00 | 2.0 | V3D-Explorer is a software application used with advanced PC hardware for the di V3D-Explorer is a software application used with advanced PC hardware for the display and 3D visualization of DICOM 3.0 compliant medical images derived from CT, MRI, PET and SPECT scans. The linear, angular and volume measurement features provided in the software for the evaluation and quantification of organ, hard and soft tissues as well as internal organ structures for lesion, mass and other anomalies. It also supports interactive segmentation of any organ. | V3D-Explorer | VIATRONIX INCORPORATED | |
6 | B209VC4X1X2X330 | 4.1.2.33 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
7 | B209VC4X1X2X320 | 4.1.2.32 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
8 | B209VC4X1X2X110 | 4.1.2.11 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
9 | B209VC4X1X1X150 | 4.1.1.15 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
10 | B209VC4X0X3X40 | 4.0.3.4 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
11 | B209VC4X0X3X13F0 | 4.0.3.13 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
12 | B209VC4X0X0X44F0 | 4.0.0.44 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
13 | B209VC4X0X0X360 | 4.0.0.36 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
14 | B209VC3X3X3X10 | 3.3.3.1 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
15 | B209VA2X00 | 2.0 | V3D-Vascular is a software application used with advanced PC hardware for evalua V3D-Vascular is a software application used with advanced PC hardware for evaluating scanned images of selected vessels. It is designed to aid the physician in analyzing the vascular system based on DICOM 3.0 compliant images from CT or MR scan. | V3D-Vascular | VIATRONIX INCORPORATED | |
16 | B198HMV11R70 | 11.7 | HMV11R7 | HealthMyne | HEALTHMYNE, INC. | |
17 | B198HMV11R50 | 11.5 | HealthMyne | HEALTHMYNE, INC. | ||
18 | B198HMV11R40 | 11.4 | HealthMyne | HEALTHMYNE, INC. | ||
19 | B198HMV11R30 | 11.3 | HealthMyne | HEALTHMYNE, INC. | ||
20 | B198HMV11R1PK0 | 11.1 | HealthMyne | HEALTHMYNE, INC. | ||
21 | B198HM01220 | 12.2 | HealthMyne | HEALTHMYNE, INC. | ||
22 | B198HM01210 | 12.1 | HealthMyne | HEALTHMYNE, INC. | ||
23 | B198HM0120 | 12.0 | HMV12 | HealthMyne | HEALTHMYNE, INC. | |
24 | B198HM01160 | 11.6 | HealthMyne | HEALTHMYNE, INC. | ||
25 | B198HM0110 | 11.0 | HealthMyne | HEALTHMYNE, INC. | ||
26 | B198HM0102 | 10.2 | HealthMyne | HEALTHMYNE, INC. | ||
27 | B198HM0101 | 10.1 | HealthMyne | HEALTHMYNE, INC. | ||
28 | B198HM0100 | 10.0 | HealthMyne | HEALTHMYNE, INC. | ||
29 | B198HM0090 | 9.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
30 | B198HM0083 | 8.3 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
31 | B198HM0082 | 8.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
32 | B198HM0081 | 8.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
33 | B198HM0080 | 8.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
34 | B198HM0071 | 7.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
35 | B198HM0070 | 7.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
36 | B198HM0063 | 6.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
37 | B198HM0062 | 6.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
38 | B198HM0061 | 6.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
39 | B198HM0060 | 6.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
40 | B198HM0051 | 5.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
41 | B198HM0050 | 5.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
42 | B198HM0042 | 4.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
43 | B198HM0040 | 4.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
44 | B198HM0030 | 3.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
45 | B198HM0020 | 2.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
46 | B198HM0010 | 1.6 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
47 | B1984M0011R20 | 11.2 | HealthMyne | HEALTHMYNE, INC. | ||
48 | B193IMD3B0 | IMD-3B | ImageGrid Radiology Viewer System is a device that receives medical images and d ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. | IMAGEGRID RADIOLOGY VIEWER SYSTEM | CANDELIS, INC. | |
49 | B193IMD3203B0 | IMD320-3B | ImageGrid Radiology Viewer System is a device that receives medical images and d ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. | IMAGEGRID RADIOLOGY VIEWER SYSTEM | CANDELIS, INC. | |
50 | B193IMD3202B0 | IMD320-2B | ImageGrid Radiology Viewer System is a device that receives medical images and d ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. | IMAGEGRID RADIOLOGY VIEWER SYSTEM | CANDELIS, INC. |