510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K070195Substantially Equivalent

Broadsound, Al3c34a,al7l50a, Al3c79b,al7l24b, At3p42a, At3c52b, Atl5l40b, At3p32a, At3c42b

Broadsound Corporation, Juipei City, Hsinchu, TW / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070195 is the FDA 510(k) clearance record for BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B, a class II device, cleared for Broadsound Corporation on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list one 510(k) clearance for Broadsound Corporation. As of , FDA records show no recalls naming K070195.

Clearance record

Decision date
Received
(266 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Broadsound Corporation 5f, #31 Shintai Rd., Juipei City, Hsinchu, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ITX

Trailing 12 months
6 clearances under product code ITX in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code ITX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20262
September 20261
October 20260