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No Description
OXOS Medical, Inc.
K1
In Commercial Distribution
- 00860008892737 ()
- Hand-held basic diagnostic x-ray system, digital
No Description
OXOS Medical, Inc.
H1
In Commercial Distribution
- 00860008892713 ()
- Hand-held basic diagnostic x-ray system, digital
No Description
OXOS Medical, Inc.
F1
In Commercial Distribution
- 00860008892706 ()
- Hand-held basic diagnostic x-ray system, digital
No Description
MULTIFUNCTIONAL IMAGING, LLC
v1
In Commercial Distribution
- 00860059002109 ()
- PET system application software
No Description
Icad, Inc.
2.1
In Commercial Distribution
- 00858012005960 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
V2
Not in Commercial Distribution
- 00858012005939 ()
- Basic diagnostic x-ray system application software
"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.
Icad, Inc.
V3.4
In Commercial Distribution
- 00858012005922 ()
D70141, D70142, D70160
- Basic diagnostic x-ray system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005915 ()
CT-102
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005908 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005892 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT system application software