Other products from "HOLOGIC, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 15420045515031 2050-0104 2050-0104 MWP Cabinet, x-ray system 2 FAXITRON PATH
2 15420045514089 R15 R15 GDF GUIDE, NEEDLE, SURGICAL 1 PERL
3 15420045506909 Discovery C KGI Densitometer, bone 2 Discovey C
4 15420045504110 ATEC Sapphire 200 KNW INSTRUMENT, BIOPSY 2 ATEC Sapphire 200
5 15420045510333 50-250XL HIH HYSTEROSCOPE (AND ACCESSORIES) 2 MYOSURE XL HYSTEROSCOPY SET
6 15420045514294 V5 NSV5US-001 MNB Device, thermal ablation, endometrial 3 NovaSure
7 25420045510330 50-250XL HIH HYSTEROSCOPE (AND ACCESSORIES) 2 MYOSURE XL HYSTEROSCOPY SET
8 25420045514307 V5 NSV5KITUS-001 MNB Device, thermal ablation, endometrial 3 NovaSure
9 25420045505107 40-902 40-902 HIH HYSTEROSCOPE (AND ACCESSORIES) 2 MyoSure Tissue Removal Device
10 15420045514836 PATHVISION 23x29 PATHVISION23X29 MWP Cabinet, x-ray system 2 FAXITRON PATH
11 15420045514300 V5 NSV5KITUS-001 MNB Device, thermal ablation, endometrial 3 NovaSure
12 15420045512924 INTERNAL CONTROL-B, 960T, IVD PRD-06234 JJH CLINICAL SAMPLE CONCENTRATOR 1 Panther Fusion
13 15420045512917 EXTRACTION REAGENTS-B, 960T, IVD PRD-06232 JJH CLINICAL SAMPLE CONCENTRATOR 1 Panther Fusion
14 15420045510906 GBS CTRLS KIT, PANTHER FUSION, IVD PRD-04485 NJR Nucleic acid amplification assay system, group b streptococcus, direct specimen test 1 Panther Fusion
15 15420045510890 GBS KIT, 96T, IVD PRD-04484 NJR Nucleic acid amplification assay system, group b streptococcus, direct specimen test 1 Panther Fusion
16 15420045510470 INTERNAL CONTROL-X, 960T, IVD PRD-04476 NJR Nucleic acid amplification assay system, group b streptococcus, direct specimen test 1 Panther Fusion
17 15420045510463 EXTRACTION REAGENT-X, 960T, IVD PRD-04477 NJR Nucleic acid amplification assay system, group b streptococcus, direct specimen test 1 Panther Fusion
18 15420045509641 System Software InSight FD OXO Image-intensified fluoroscopic x-ray system, mobile 2 Flouroscan InSight
19 15420045509375 CLASS I CONTROL - C. ALBICANS PRD-04521 JJX Single (specified) analyte controls (assayed and unassayed) 1 aptima
20 15420045507937 20-401ML 20-401ML NWW Hysteroscope accessories Myosure Manual Tissue Removal Device
21 15420045505230 B90003 B90003 JAQ System, applicator, radionuclide, remote-controlled 2 4.0-5.0 CM CT LUMEN MARKER SET
22 15420045505193 B11245 B11245 JAQ System, applicator, radionuclide, remote-controlled 2 4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER
23 15420045505094 50-501XL 50-501XL HIH HYSTEROSCOPE (AND ACCESSORIES) MyoSure Tissue Removal Device
24 15420045505087 50-401XL 50-401XL HIH HYSTEROSCOPE (AND ACCESSORIES) 2 MyoSure Tissue Removal Device
25 15420045505070 30-401LITE 30-401LITE HIH HYSTEROSCOPE (AND ACCESSORIES) MyoSure Tissue Removal Device
26 15420045505001 919007-01 919007-01 JAQ System, applicator, radionuclide, remote-controlled Mammosite Variable 4-5 cm Applicator Tray
27 15420045504998 EVIVA_1213-20 EVIVA_1213-20 KNW INSTRUMENT, BIOPSY EVIVA_1213-20
28 15420045504950 EVIVA_0910-20 EVIVA_0910-20 KNW INSTRUMENT, BIOPSY EVIVA_0910-20
29 15420045504813 10-401 10-401 HIH HYSTEROSCOPE (AND ACCESSORIES) MyoSure Tissue Removal Device
30 15420045501140 2000 NS2000US MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL NovaSure
31 15420045501133 2007 NS2007US MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL NovaSure SureSound
32 15420045501126 2013 NS2013KITUS MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL NovaSure SureSound
33 15420045501119 2013 NS2013US MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL NovaSure
34 15420045501065 Cervista HTA System Computer MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 Cervista HTA System
35 15420045500969 Cervista HTA System MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 Cervista HTA System
36 15420045500952 Cervista HTA System MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 Cervista HTA System
37 15420045500860 NovaSure Controller MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL 3 NovaSure
38 15420045500853 NovaSure Controller MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL 3 NovaSure
39 15420045512474 GENIUS AI DETECTION SOFTWARE OTE Digital breast tomosynthesis 3 GENIUS AI DETECTION
40 25420045510064 FILTER, THINPREP UROCYTE 100 PACK   70472-001 KET FILTERS, CELL COLLECTION, TISSUE PROCESSING ThinPrep
41 25420045510057 THINPREP SLIDES UROCYTE, 100 pk 70471-001 KEW SLIDES, MICROSCOPE ThinPrep
42 25420045509990 THINPREP MICROSCOPE, ARCLESS, 72pk 70126-002 KEW SLIDES, MICROSCOPE ThinPrep
43 25420045509679 NON-GYN Slides 70372-001 KEW SLIDES, MICROSCOPE ThinPrep
44 25420045509662 NON-GYN Filters, 100 pack 70205-001 KET FILTERS, CELL COLLECTION, TISSUE PROCESSING ThinPrep
45 25420045508467 UroCyte Vial 70473-001  LEA PRESERVATIVE, CYTOLOGICAL 1 ThinPrep
46 25420045505039 819001 819001 JAQ System, applicator, radionuclide, remote-controlled 2 Neucletron HDR Afterloader Connectors wObturators
47 15420045514775 PRESERVCYT VIAL PRD-07129 LEA PRESERVATIVE, CYTOLOGICAL 1 ThinPrep
48 15420045514621 UroCyte Vial ASY-15509 LEA PRESERVATIVE, CYTOLOGICAL 1 ThinPrep
49 15420045514614 CytoLyt Cup PRD-07065 LEA PRESERVATIVE, CYTOLOGICAL 1 ThinPrep
50 15420045514607 CytoLyt Tube PRD-07064 LEA PRESERVATIVE, CYTOLOGICAL 1 ThinPrep
Other products with the same Product Code "MYN"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00868430000027 5.2 Logicon Caries Detector is a software tool for assisting in the diagnosis of pro Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. Logicon Caries Detector v5.2 has a "Prescan" feature, a method for automatically scanning all of the interproximal surfaces in a bitewing radiograph of posterior teeth for interproximal caries. It displays caries outlines for all surfaces in one radiograph on one screen and allows dentist to view (1) screen result details (density change and decay probability for each outline), (2) save clinically important results and (3) explore others with the ROI tool. Doctor can build his own final diagnostic results screen combining his own manual results and adjusted PreScan results. PreScan uses same caries detection algorithms as original device; but now automatically opens the V-tool on each interproximal surface. Logicon Caries Detector G. A INDUSTRIES
2 00868430000010 5.1 Logicon Caries Detector is a software tool for assisting in the diagnosis of pro Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. PreScan is a New Feature in Logicon Caries Detector v5.1. It is a method for automatically scanning all the interproximal surfaces in a bitewing radiograph of posterior teeth for interproximal caries. It displays caries outlines for all surfaces in one radiograph on one screen and allows dentist to view (1) screen result details (density change and decay probability for each outline), (2) save clinically important results and (3) explore others with the ROI tool. Doctor can build his own final diagnostic results screen. PreScan uses same caries detection algorithms as original device; but now automatically opens the V-tool on each interproximal surface. Logicon Caries Detector G. A INDUSTRIES
3 00868430000003 4.0 Logicon Caries Detector is a software tool for assisting in the diagnosis of pro Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. Logicon Caries Detector G. A INDUSTRIES
4 00858012005878 V1.1 DSC014-03-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. PowerLook PRO with Tomo Detection ICAD, INC.
5 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. Powerlook PRO with SLD, FRU ICAD, INC.
6 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. Powerlook PRO with SLD, GE, US ICAD, INC.
7 00858012005847 V7.2 DSC017-04-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. PowerLook AMP PRO, SLD, GE, ROW ICAD, INC.
8 00858012005830 V7.2 DSC017-01-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. PowerLook AMP PRO, SLD, GE, ROW ICAD, INC.
9 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. Powerlook PRO Hardware Upgrade, SLD ICAD, INC.
10 00858012005816 V7.2 DSC017-03-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. PowerLook to PowerLook PRO Upgrade, US ICAD, INC.
11 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. Powerlook PRO Hardware Upgrade, SLD ICAD, INC.
12 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. Powerlook PRO Hardware Upgrade, SLD ICAD, INC.
13 00858012005663 V1.1 D70133 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. PowerLook Tomo Detection and SecondLook Digital License ICAD, INC.
14 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. PowerLook AMP PRO with SecondLook Digital ICAD, INC.
15 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. PowerLook PRO Tomo Detection FRU ICAD, INC.
16 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. PowerLook PRO Tomo Detection and SLD, GE ICAD, INC.
17 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. PowerLook PRO with Tomo Detection, Upgrade, GE ICAD, INC.
18 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. PowerLook PRO Tomo Detection and SLD, GE ICAD, INC.
19 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. PowerLook PRO Tomo Detection and SLD, GE ICAD, INC.
20 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. PowerLook Tomo Detection Software ICAD, INC.
21 00858012005175 DSC010-09 PowerLook AMP SLD Agfa CR ICAD, INC.
22 00858012005168 DSC010-08 PowerLook AMP SLD Planmed ICAD, INC.
23 00858012005151 DSC010-07-EU PowerLook AMP SLD Philips OUS ICAD, INC.
24 00858012005144 DSC010-06 PowerLook AMP SLD Giotto ICAD, INC.
25 00858012005137 DSC010-05-EU PowerLook AMP SLD Hologic OUS ICAD, INC.
26 00858012005120 DSC010-04-EU PowerLook AMP SLD Fuji OUS ICAD, INC.
27 00858012005113 DSC010-03-EU PowerLook AMP SLD Siemens OUS ICAD, INC.
28 00858012005106 DSC010-12-EU PowerLook AMP SLD GE OUS Direct ICAD, INC.
29 00858012005090 DSC010-01-EU PowerLook AMP SLD GE OUS ICAD, INC.
30 00858012005083 V7.2 2376858-8-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.Field Replacement System PowerLook AMP SLD FRU GE ICAD, INC.
31 00858012005076 V7.2 D4D0147 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.Field Replacement System PowerLook AMP SLD FRU ICAD, INC.
32 00858012005069 V7.2 DSC010-07-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. PowerLook AMP SLD Philips ICAD, INC.
33 00858012005052 V7.2 DSC010-05-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. PowerLook AMP SLD Hologic ICAD, INC.
34 00858012005045 V7.2 DSC010-04-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. PowerLook AMP SLD Fuji ICAD, INC.
35 00858012005038 V7.2 DSC010-03-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. PowerLook AMP SLD Siemens ICAD, INC.
36 00858012005021 V7.2 DSC010-12-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. PowerLook AMP SLD GE Direct ICAD, INC.
37 00858012005014 V7.2 DSC010-01-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. PowerLook AMP SLD GE US ICAD, INC.
38 00858012005007 V7.2 DS0206 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. SecondLook Digital (SLD) ICAD, INC.
39 00852491008023 1.0.0 Chest-CAD is a computer-assisted detection (CADe) software device designed as a Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD uses machine learning techniques to identify, highlight, and categorize suspicious regions of interest (ROI) in adult chest X-rays. Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. 00852491008016 Chest-CAD IMAGEN TECHNOLOGIES, INC.
40 00196852162192 VCA01B Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions.Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older. Videa Caries Assist VIDEAHEALTH, INC.
41 B630QVCSIK1010344 10.10-3.4.4 Installation Kit for QVCAD System Release 3.4.4 with Debian 10.10 QVCAD System Installation Kit QVIEW MEDICAL
42 B630QVCSIK1010343 10.10-3.4.3 Installation Kit for QVCAD System Release 3.4.3 with Debian 10.10 QVCAD System Installation Kit QVIEW MEDICAL
43 B630QVCS344 3.4.4 Computer aided detection system of suspicious lesions in automated breast ultras Computer aided detection system of suspicious lesions in automated breast ultrasound images. QVCAD System QVIEW MEDICAL
44 B630QVCS343 3.4.3 QVCAD System QVIEW MEDICAL
45 B630QVCS342 3.4.2 QVCAD System QVIEW MEDICAL
46 B630QVCS34 3.4 QVCAD System QVIEW MEDICAL
47 B630QVCS33 3.3 QVCAD System QVIEW MEDICAL
48 60889978008698 Logicon Caries Detector 8008690 LOGICON SITE LIC (UP TO 10) W/IWT Logicon Caries Detector CARESTREAM HEALTH, INC.
49 60192156851628 Logicon Caries Detector 8008690 LOGICON SITE LIC (UP TO 10) W/IWT Logicon Caries Detector CARESTREAM DENTAL LLC
50 60192155942754 Logicon Caries Detector 5942750 CSD LOGICON CARIES DETECTOR Logicon Caries Detector CARESTREAM DENTAL LLC