510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252947Substantially Equivalent

HistoSonics® Planning Tool

Histosonics, Inc, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252947 is the FDA 510(k) clearance record for HistoSonics® Planning Tool, a class II device, cleared for HistoSonics, Inc. on under FDA product code QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation). FDA's definition for product code QTZ reads: "To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy". FDA records list 4 510(k) clearances for HistoSonics, Inc., from to . As of , FDA records show no recalls naming K252947.

Clearance record

Decision date
Received
(256 days to decision)
Product code
QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
HistoSonics, Inc. 16305 36th Ave. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QTZ

Trailing 12 months
2 clearances under product code QTZ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QTZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260