510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K190314Substantially Equivalent

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000

Mednovel Technology, Ltd., Milpitas CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190314 is the FDA 510(k) clearance record for Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000, a class II device, cleared for Mednovel Technology, Ltd. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list one 510(k) clearance for Mednovel Technology, Ltd. As of , FDA records show no recalls naming K190314.

Clearance record

Decision date
Received
(238 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Mednovel Technology, Ltd. 1154 Cadillac Ct., Milpitas CA
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