510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K013620Substantially Equivalent

Medstone, Uropro 2000, Tomographic Option

Medstone Intl., Inc., Aliso Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013620 is the FDA 510(k) clearance record for MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION, a class II device, cleared for Medstone Intl., Inc. on under FDA product code IZF (System, X-Ray, Tomographic). FDA records list 3 510(k) clearances for Medstone Intl., Inc., from to . As of , FDA records show no recalls naming K013620.

Clearance record

Decision date
Received
(78 days to decision)
Product code
IZF System, X-Ray, Tomographic
Regulation
21 CFR 892.1740
Device class
Class II
Review panel
Radiology
Applicant
Medstone Intl., Inc. 100 Columbia, Suite 100, Aliso Viejo CA
510(k) summary
Summary
Third party review
No

Clearances, product code IZF

Trailing 12 months
2 clearances under product code IZF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260