Last synced on 24 May 2024 at 11:04 pm

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Page Type
Product Code
Definition
A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
Physical State
Software device that receives radiological images as an input and provides the user with the identification and characterization of suspicious lesions as an output.
Technical Method
Analyzes radiological images using machine learning algorithms to detect and diagnose lesions suspicious for cancer.
Target Area
Anatomical sites that may contain lesions suspicious for cancer.
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.2090
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QDQ is linked to regulation 21CFR892.2090, which does not seem to exist yet. It may be pending at the moment.

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Page Type
Product Code
Definition
A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
Physical State
Software device that receives radiological images as an input and provides the user with the identification and characterization of suspicious lesions as an output.
Technical Method
Analyzes radiological images using machine learning algorithms to detect and diagnose lesions suspicious for cancer.
Target Area
Anatomical sites that may contain lesions suspicious for cancer.
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.2090
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QDQ is linked to regulation 21CFR892.2090, which does not seem to exist yet. It may be pending at the moment.