510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QVDClass II

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

21 CFR 892.2055 / Radiology
FDA source (opens on fda.gov)

QVD is the FDA product code for Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan, a class II device type, regulated under 21 CFR 892.2055. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QVD
Device name
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
FDA 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.
Regulation
21 CFR 892.2055
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QVD

By decision year
1 clearance under product code QVD with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QVD by decision year
YearClearances
20231

Applicants with the most clearances

Product code QVD
Applicants holding the most 510(k) clearances under product code QVD
ApplicantClearances
Caption Health1

Companies listing this code with FDA

Companies whose registered establishments list this code