510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190786Substantially Equivalent

Eye Prime

Ellex Medical Pty Ltd, Mawson Lakes, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190786 is the FDA 510(k) clearance record for Eye Prime, a class II device, cleared for Ellex Medical Pty, Ltd. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 13 510(k) clearances for Ellex Medical Pty, Ltd., from to . As of , FDA records show no recalls naming K190786.

Clearance record

Decision date
Received
(15 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Ellex Medical Pty, Ltd. 3-4 Second Ave. Mawson Lakes, Mawson Lakes, AU
510(k) summary
Summary PDF
Third party review
Yes

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