DeviceClearance

Product code QIH— Radiology

LVivo Software Application

Classification name
Automated Radiological Image Processing Software
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
329
First cleared
Most recent

FDA classification definition

“To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.”

— U.S. Food and Drug Administration, device classification record for product code QIH under 21 CFR 892.2050, via openFDA

Market context for product code QIH

FDA has cleared 329 devices under product code QIH between 2019 and 2026, filed by 189 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QIH

Recent clearances under product code QIH

1–100 of 329

Data sourced from openFDA. This site is unofficial and independent of the FDA.