510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K023430Substantially Equivalent

Uf Brachytherapy Stand

University of Florida, Chevy Chase MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023430 is the FDA 510(k) clearance record for UF BRACHYTHERAPY STAND, a class II device, cleared for University of Florida on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list one 510(k) clearance for University of Florida. As of , FDA records show no recalls naming K023430.

Clearance record

Decision date
Received
(256 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
University of Florida 5610 Wisconsin Ave., #304, Chevy Chase MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYO

Trailing 12 months
8 clearances under product code IYO in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260