QVD · Class II · 21 CFR 892.2055

FDA Product Code QVD: Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

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.

Leading manufacturers include Caption Health, Inc..

1
Total
0
Cleared
149d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan Devices (Product Code QVD)

1 devices
1–1 of 1
Not Cleared Feb 24, 2023
Caption Interpretation Automated Ejection Fraction Software
DEN220063
Caption Health, Inc.
Radiology · 149d

About Product Code QVD - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QVD since 2023, with 0 receiving FDA clearance (average review time: 149 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QVD devices are reviewed by the Radiology panel. Browse all Radiology devices →