| Device |
software algorithm device to assist users in digital pathology |
| Regulation Description |
Software algorithm device to assist users in digital pathology. |
| Definition |
A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis. |
| Physical State |
Software device that receives digitized pathology glass slide images as an input and provides the user with the identification, location and/or characterization of suspicious area(s) on the image as an output. |
| Technical Method |
Analyzes digitized pathology glass slide images using machine learning algorithms to detect and diagnose lesions suspicious for cancer. |
| Target Area |
Human tissue biopsy digital images. |
| Regulation Medical Specialty |
Pathology |
| Review Panel |
Pathology |
|---|
| Product Code | QPN |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.3750
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
