Last synced on 19 July 2024 at 11:05 pm

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Page Type
Product Code
Definition
A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.
Physical State
The subject software would utilize images acquired using an imaging system. The software can be installed on an existing imaging system, or can be operated on a computer that is connected to the imaging system.
Technical Method
The device's algorithm would be based on the analysis of images and/or diagnostic data. The underlying algorithms used for providing guidance to the users may be based on deep learning methods, trained on images obtained by trained operators.
Target Area
Human body
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.2100
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 QJU is linked to regulation 21CFR892.2100, which does not seem to exist yet. It may be pending at the moment.

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Page Type
Product Code
Definition
A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.
Physical State
The subject software would utilize images acquired using an imaging system. The software can be installed on an existing imaging system, or can be operated on a computer that is connected to the imaging system.
Technical Method
The device's algorithm would be based on the analysis of images and/or diagnostic data. The underlying algorithms used for providing guidance to the users may be based on deep learning methods, trained on images obtained by trained operators.
Target Area
Human body
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.2100
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 QJU is linked to regulation 21CFR892.2100, which does not seem to exist yet. It may be pending at the moment.