510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011955Substantially Equivalent

Modification To:accusonic Plus, Model Ap-100

Metron Medical Australia, Pty, Ltd., Carrum Downs, AU / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K011955 is the FDA 510(k) clearance record for MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100, a class II device, cleared for Metron Medical Australia, Pty, Ltd. on under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat). FDA records list 17 510(k) clearances for Metron Medical Australia, Pty, Ltd., from to . As of , FDA records show no recalls naming K011955.

Clearance record

Decision date
Received
(24 days to decision)
Product code
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5300
Device class
Class II
Review panel
Physical Medicine
Applicant
Metron Medical Australia, Pty, Ltd. 57 Aster Ave., Carrum Downs, AU
510(k) summary
Statement
Third party review
No

Clearances, product code IMI

Trailing 12 months

FDA records hold no clearances under product code IMI in the trailing twelve months.

FDA records show no clearances under product code IMI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IMI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260