510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QTZClass II

Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

21 CFR 892.2050 / Radiology
FDA source (opens on fda.gov)

QTZ is the FDA product code for Radiological Image Processing Software For Ablation Therapy Planning And Evaluation, a class II device type, regulated under 21 CFR 892.2050. FDA's definition for this code reads: "To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QTZ
Device name
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
FDA definition
To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
Regulation
21 CFR 892.2050
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
9
Ingested recalls
0

Clearances, product code QTZ

By decision year
9 clearances under product code QTZ with a decision year between 2022 and 2026, 2023 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code QTZ by decision year
YearClearances
20221
20233
20242
20251
20262

Applicants with the most clearances

Product code QTZ
Applicants holding the most 510(k) clearances under product code QTZ
ApplicantClearances
Siemens Healthcare GmbH2
Techsomed2
Eigen1
Histosonics, Inc1
MIM Software Inc1
R.A.W. S.R.L1
Techsomed Medical Technologies, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code