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
Other products with the same Product Code "JAQ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00863593000235 F-01-02-0001 The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube conta The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline solution. The HDPE tube is up to 350.0 mm in length and 1.0 mm in diameter, with the distal 19.0 mm of the tube accommodating a HDPE sealing plug. The distal end of the device is provided with an attached HDPE end-cap for handling. This end cap is approximately 3.0 mm in length. The HDR MRI Lumen Marker is an accessory to remote controlled high dose rate (HDR) radionuclide applicator systems and facilitates the identification of lumens within MRI compatible HDR brachytherapy applicators. HDR MRI Lumen Marker C4 IMAGING, LLC
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3 00858012005557 710746 CG1000 Cervical Applicator Set Cervical Applicator Set ICAD, INC.
4 00858012005540 710855 CG1002 Cervical Applicator Bundle 2 Cervical Applicator Set, Bundle 2 ICAD, INC.
5 00858012005533 710850 CG1001 Cervical Applicator Bundle 1 Cervical Applicator Set, Bundle 1 ICAD, INC.
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10 00851546007004 ALA-45 Unit Tray ALA-45 Alatus Vaginal Balloon Packing System Kit Alatus RADIADYNE, L.L.C.
11 00850645007564 SMG0242-025 Seed, Gold Marker, 5 mm, 25 ea AOS Gold Marker Seeds ALPHA-OMEGA SERVICES, INC.
12 00850645007557 SGU0010-020 Set, Universal Connecting Guide Tubes, Numbered, Series-15, 100 cm, Green Nylon, Set of 20 AOS Universal Connecting Guide Tubes ALPHA-OMEGA SERVICES, INC.
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15 00850645007526 SGU0007-015 Set, Universal Connecting Guide Tubes, Numbered, Series-17, 100 cm, Clear Teflon Set, Universal Connecting Guide Tubes, Numbered, Series-17, 100 cm, Clear Teflon, [Disposable, Set of 15 AOS Universal Connecting Guide Tubes ALPHA-OMEGA SERVICES, INC.
16 00850645007519 SAE0001-020 Set, Extension Adaptor for Stainless Steel Needles with Threaded Female Hubs, Nu Set, Extension Adaptor for Stainless Steel Needles with Threaded Female Hubs, Numbered, Series-17, 16 cm, Set of 20 AOS Extension Adaptor ALPHA-OMEGA SERVICES, INC.
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18 00850645007496 TRD0001-017 Template, Syed/Neblett/Hedger, Series-17, Rectal, (36 Holes), Blue, 1 ea AOS Rectal Template, Syed/Neblett ALPHA-OMEGA SERVICES, INC.
19 00850645007489 TRD0001-015 Template, Syed/Neblett/Hedger, Series-15, Rectal, (36 Holes), Yellow, 1 ea AOS Rectal Template, Syed/Neblett/Hedger ALPHA-OMEGA SERVICES, INC.
20 00850645007472 TPD0001-017 Template, Syed/Neblett/Hedger, Series-17, Prostate, (18 Holes), Blue, 1 ea AOS Prostate Template, Syed/Neblett/Hedger ALPHA-OMEGA SERVICES, INC.
21 00850645007465 TPD0001-015 Template, Syed/Neblett/Hedger, Series-15, Prostate, (18 Holes), Yellow, 1 ea AOS Prostate Template, Syed/Neblett/Hedger ALPHA-OMEGA SERVICES, INC.
22 00850645007458 TGD0003-017 Template, Syed/Neblett/Hedger, Series-17, GYN-3 (54 Holes), Blue, 1 ea AOS GYN-3 Template, Syed/Neblett/Hedger ALPHA-OMEGA SERVICES, INC.
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24 00850645007434 NHD0001-006 Needle, Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Needle, Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 30 cm, 10 ea AOS Stainless Steel Needle ALPHA-OMEGA SERVICES, INC.
25 00850645007427 NHD0001-005 Needle, Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Needle, Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 25 cm, 10 ea AOS Stainless Steel Needle ALPHA-OMEGA SERVICES, INC.
26 00850645007410 NHD0001-004 Needle, Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Needle, Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 20 ea AOS Stainless Steel Needle ALPHA-OMEGA SERVICES, INC.
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30 00850645007359 NFW0001-009 Needle, Flexiguide without Female Luer Adaptor and Stylet with 90 degree bend, S Needle, Flexiguide without Female Luer Adaptor and Stylet with 90 degree bend, Series-15, 20 cm, 10 ea AOS Flexiguide Needle ALPHA-OMEGA SERVICES, INC.
31 00850645007342 NFV0003-003 Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, S Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-15, 20 cm, 10 ea AOS Flexiguide Needle ALPHA-OMEGA SERVICES, INC.
32 00850645007335 NFV0002-004 Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, S Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 20 cm, 20 ea AOS Flexiguide Needle ALPHA-OMEGA SERVICES, INC.
33 00850645007328 NFV0002-003 Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, S Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 20 cm, 15 ea AOS Flexiguide Needle ALPHA-OMEGA SERVICES, INC.
34 00850645007311 NFV0002-002 Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, S Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 20 cm, 10 ea AOS Flexiguide Needle ALPHA-OMEGA SERVICES, INC.
35 00850645007298 NFV0001-004 Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, S Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-15, 25 cm, 10 ea AOS Flexiguide Needle ALPHA-OMEGA SERVICES, INC.
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