Other products from "ICAD, INC."
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
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 D7231020394 1020394 1020394 Lead-free thyroid protector beige Safco lead-free x-ray aprons SAFCO DENTAL SUPPLY CO.
2 D7231020390 1020390 1020390 Lead-free thyroid protector blue Safco lead-free x-ray aprons SAFCO DENTAL SUPPLY CO.
3 00075020035011 DIS558/01 Philips Zoom DISCUS DENTAL, LLC
4 10860004894671 SS-5100-XL Multi-purpose shield provides excellent protection during many types of procedur Multi-purpose shield provides excellent protection during many types of procedures. Provides a comprehensive zone of protection for the head, hands and body of the entire team. SecureShield© Multipurpose 12" x 36" Scatter Reducing Drape BARRIER TECHNOLOGIES, LLC
5 10860004894664 SS-7200 Outstanding protection during dialysis declotting procedures. Up to 80+% and 50 Outstanding protection during dialysis declotting procedures. Up to 80+% and 50% exposure reductions at hands and eyes, respectively. Shielding is easily adjustable as needed. Clinically proven to attenuate 95% of a 100kV direct beam. SecureShield Dialysis Access pads provide excellent protection for interventionalists and their teams during DADD procedures. SecureShield© for Dialysis 42" x 32" Scatter Reducing Drape BARRIER TECHNOLOGIES, LLC
6 10860004894657 SS-5400 Excellent protection for device implant procedures such as Bi-V pacing, etc. Spe Excellent protection for device implant procedures such as Bi-V pacing, etc. Specially designed scoop fenestration allows easy access to site and maximum radiation protection. Specifically designed to protect the physician’s hand, body and head. The unique half-moon fenestration is large enough to allow easy access at the entry point, but small enough to block dangerous scatter radiation. SecureShield© EP 12" x 17" Scatter Reducing Drape BARRIER TECHNOLOGIES, LLC
7 10860004894640 SS-5300 Ultimate protection for femoral artery and radial access procedures. Unique shie Ultimate protection for femoral artery and radial access procedures. Unique shield design protects hands, face and body. Will not inhibit the physicians technique. The small fenestration and the slit to the shield edge provide maximum protection to hands and body and excellent maneuverability around the sheath. SecureShield© Angiography 13" x 16" Scatter Reducing Drape BARRIER TECHNOLOGIES, LLC
8 10860004894633 SS-5200 Outstanding protection during all types of biopsy procedures. Rectangular fenes Outstanding protection during all types of biopsy procedures. Rectangular fenestration allows access and viewing while minimizing radiation exposure. The SecureShield Biopsy Shield provides excellent protection during any needle biopsy or puncture procedure. This versatile shield can be effectively used at any location on the body. SecureShield© Multipurpose with fenestration 12" x 17" Scatter Reducing Drape BARRIER TECHNOLOGIES, LLC
9 10810101310482 ACF-FMHB-9RU Disposable Anti-Fog Face Shield. Full Length, Foam Head Protection, Elastic Head Disposable Anti-Fog Face Shield. Full Length, Foam Head Protection, Elastic Head Band. Regular/Large Paneffort PANEFFORT, LLC
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16 08054301890206 SleeveS SleeveS Radiation Reducing Sleeves Protech Proguard EMERSON & CO SRL
17 04251339903777 UT6032 UT Radiation Lower Body Protection UT MAVIG GMBH
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19 04251339903753 UT6030 UT Radiation Lower Body Protection UT MAVIG GMBH
20 04251339903746 UT6020-SI UT Radiation Lower Body Protection UT MAVIG GMBH
21 04251339903739 UT6020-GE UT Radiation Lower Body Protection UT MAVIG GMBH
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32 03701444300257 CORNING® MED-X ® GLASS - 5-6.5 MM Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuat Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications. Corning® Med-X ® Glass CORNING SAS
33 03701444300240 CORNING® MED-X ® GLASS - 5.7-7 MM Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuat Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications Corning® Med-X ® Glass CORNING SAS
34 03701444300233 CORNING® MED-X ® GLASS - 7-8.5 MM Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuat Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications Corning® Med-X ® Glass CORNING SAS
35 03701444300226 CORNING® MED-X ® GLASS - 8.5-10 MM Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuat Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications. Corning® Med-X ® Glass CORNING SAS
36 03701444300219 CORNING® MED-X ® GLASS - 10-12 MM Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuat Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications. Corning® Med-X ® Glass CORNING SAS
37 03701444300202 CORNING® MED-X ® GLASS - 11-13 MM Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuat Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications. Corning® Med-X ® Glass CORNING SAS
38 03701444300196 CORNING® MED-X ® GLASS - 12-14 MM Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuat Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications. Corning® Med-X ® Glass CORNING SAS
39 03701444300189 CORNING® MED-X ® GLASS - 14-16 MM Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuat Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications. Corning® Med-X ® Glass CORNING SAS
40 03701444300172 CORNING® MED-X ® GLASS - 16-18 MM Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuat Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications. Corning® Med-X ® Glass CORNING SAS
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