← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

QTZ — Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

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

DEVICE CLASS
Class II
REGULATION
21 CFR 892.2050
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K253264Siemens Healthcare GmbH · 510k2026-06-16
K252947HistoSonics, Inc. · 510k2026-05-29
K251931Techsomed Medical Technologies · 510k2025-09-08

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →