BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B— 510(k) K070195

Name: FDA 510(k) clearance K070195
Creator: U.S. Food and Drug Administration
Published: 2007-10-15

Substantially Equivalent

Broadsound Corporation

FDA 510(k) clearance K070195 for BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B, Substantially Equivalent on 2007-10-15. Applicant: Broadsound Corporation. Device class: 2.

Clearance details

Applicant: Broadsound Corporation
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2007-01-22
Decision date: 2007-10-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Juipei City, Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.