Other products from "FOCAL HEALTHCARE INC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00628055858010 2.0 Fusion Bx 2.0 is designed to display the 2D live video received from commerciall Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure. LLZ System, Image Processing, Radiological 2 Fusion Bx
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
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6 00810035220379 5 A software application to facilitate management, distribution, and/or viewing of A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation. Radmedix AccuVue+ RADMEDIX, LLC
7 00810007631103 ZB-3D208 ZB-3D208 ANATOMICAL MODEL, RIB, SINGLE AccuModel® MEDCAD
8 00810007631073 ACS_GU ACS_GU ANATOMICAL MODEL, GUIDE AccuModel MEDCAD
9 00810007630861 ZB-3D108 ZB-3D108 ANATOMICAL MODEL, FIBULA AccuModel® MEDCAD
10 00810007630854 ZB-3D207 ZB-3D207 ANATOMICAL MODEL, SKULL AND MANDIBLE (FUSED) AccuModel® MEDCAD
11 00810007630847 ZB-3D206 ZB-3D206 ANATOMICAL MODEL, SKULL AccuModel® MEDCAD
12 00810007630830 ZB-3D204 ZB-3D204 ANATOMICAL MODEL, MANDIBLE AND MAXILLA AccuModel® MEDCAD
13 00810007630823 ZB-3D203 ZB-3D203 ANATOMICAL MODEL, MAXILLA AccuModel® MEDCAD
14 00810007630816 ZB-3D202 ZB-3D202 ANATOMICAL MODEL, MANDIBLE AccuModel® MEDCAD
15 00810007630809 ZB-3D102 ZB-3D102 ANATOMICAL MODEL, GRAFT AccuModel® MEDCAD
16 00810007630793 ZB-3D101 ZB-3D101 ANATOMICAL MODEL, IMPLANT MODEL AccuModel® MEDCAD
17 00810007630786 ZB-3D100 ZB-3D100 ANATOMICAL MODEL, HOST BONE PERI-DEFECT AccuModel® MEDCAD
18 00810007630779 ZB-3D-M ZB-3D-M ANATOMICAL MODEL, MISCELLANEOUS AccuModel® MEDCAD
19 00810007630762 ZB-K030 ZB-K030 MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ PLATE DESIGN AccuPlan® System MEDCAD
20 00810007630755 ZB-K021 ZB-K021 MIDFACE RECONSTRUCTION, SURGICAL GUIDE AccuPlan® System MEDCAD
21 00810007630748 ZB-K020-R ZB-K020-R MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT AccuPlan® System MEDCAD
22 00810007630731 ZB-K020 ZB-K020 MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT AccuPlan® System MEDCAD
23 00810007630724 ZB-K011 ZB-K011 MANDIBLE RECONSTRUCTION, SURGICAL GUIDE AccuPlan® System MEDCAD
24 00810007630717 ZB-K010-R ZB-K010-R MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT AccuPlan® System MEDCAD
25 00810007630700 ZB-K010 ZB-K010 MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT AccuPlan® System MEDCAD
26 00810007630694 ZB-K004 ZB-K004 ORTHOGNATHIC, SURGICAL GUIDE AccuPlan® System MEDCAD
27 00810007630687 ZB-K003 ZB-K003 ORTHOGNATHIC, 3D PRINTED DENTAL MODELS AccuPlan® System MEDCAD
28 00810007630670 ZB-K002 ZB-K002 ORTHOGNATHIC, FINAL SPLINT AccuPlan® System MEDCAD
29 00810007630663 ZB-K001 ZB-K001 ORTHOGNATHIC, INTERMEDIATE SPLINT AccuPlan® System MEDCAD
30 00810007630656 ZB-K000-R ZB-K000-R ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT AccuPlan® System MEDCAD
31 00810007630649 ZB-K000 ZB-K000 ORTHOGNATHIC, SURGICAL PLANNING KIT AccuPlan® System MEDCAD
32 00810007630533 MC-K000-R MC-K000-R ORTHOGNATHIC, SURGICAL PLANNING KIT - REPORT AccuPlan System MEDCAD
33 00810007630441 MC-K020-R MC-K020-R MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT AccuPlan System MEDCAD
34 00810007630427 MC-K020 MC-K020 MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT AccuPlan System MEDCAD
35 00810007630373 MC-K021 MC-K021 MIDFACE RECONSTRUCTION, SURGICAL GUIDE AccuPlan System MEDCAD
36 00810007630366 MC-K011 MC-K011 MANDIBLE RECONSTRUCTION, SURGICAL GUIDE AccuPlan System MEDCAD
37 00810007630359 MC-K010-R MC-K010-R MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT AccuPlan System MEDCAD
38 00810007630342 MC-K004 MC-K004 ORTHOGNATHIC, SURGICAL GUIDE AccuPlan System MEDCAD
39 00810007630335 MC-K010 MC-K010 MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT AccuPlan System MEDCAD
40 00810007630328 MC-K003 MC-K003 ORTHOGNATHIC, 3D PRINTED DENTAL MODELS AccuPlan System MEDCAD
41 00810007630311 MC-K002 MC-K002 ORTHOGNATHIC, FINAL SPLINT AccuPlan System MEDCAD
42 00810007630304 MC-K001 MC-K001 ORTHOGNATHIC, INTERMEDIATE SPLINT AccuPlan System MEDCAD
43 00810007630298 MC-K000 MC-K000 ORTHOGNATHIC, SURGICAL PLANNING KIT AccuPlan System MEDCAD
44 00810007630281 MC-3D207 MC-3D207 ANATOMICAL MODEL, SKULL AND MANDIBLE (FUSED) AccuModel MEDCAD
45 00810007630274 MC-3D206 MC-3D206 ANATOMICAL MODEL, SKULL AccuModel MEDCAD
46 00810007630267 MC-3D204 MC-3D204 ANATOMICAL MODEL, MANDIBLE AND MAXILLA AccuModel MEDCAD
47 00810007630250 MC-3D203 MC-3D203 ANATOMICAL MODEL, MAXILLA AccuModel MEDCAD
48 00810007630243 MC-3D202 MC-3D202 ANATOMICAL MODEL, MANDIBLE AccuModel MEDCAD
49 00810007630236 MC-3D109 MC-3D109 ANATOMICAL MODEL, GUIDE AccuModel MEDCAD
50 00810007630229 MC-3D108 MC-3D108 ANATOMICAL MODEL, FIBULA AccuModel MEDCAD