DeviceClearance

Product code QTZ— Radiology

VisAble.IO

Classification name
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
9
First cleared
Most recent

FDA classification definition

“To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.”

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

Market context for product code QTZ

FDA has cleared 9 devices under product code QTZ between 2022 and 2026, filed by 7 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 QTZ

Recent clearances under product code QTZ

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