Device |
chest x-ray computer aided detection |
Regulation Description |
Medical image management and processing system. |
Definition |
To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review. |
Physical State |
Software device. |
Technical Method |
Detection algorithm searches for and identifies potential nodules on images of the chest acquired using x-ray. |
Target Area |
Chest |
Regulation Medical Specialty |
Radiology |
Review Panel |
Radiology |
Product Code | OMJ |
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
|
Third Party Review |
Not Third Party Eligible |