Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
QVD · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2055
Classification
FDA Product Code
QVD
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.2055
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan.