Device |
lung computed tomography system, computer-aided detection |
Regulation Description |
Medical image management and processing system. |
Definition |
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR. |
Physical State |
Software device. |
Technical Method |
Detection algorithm searches for and identifies potential nodules on images of the chest acquired using multi-slice computed tomography (msct). |
Target Area |
Lung |
Regulation Medical Specialty |
Radiology |
Review Panel |
Radiology |
Product Code | OEB |
Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging Devices and Electronic Products
(DHT8B)
|
Submission Type |
510(k)
|
Regulation Number |
892.2050
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |