TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS— 510(k) K112953

Substantially Equivalent

Teratech Corp.

FDA 510(k) clearance K112953 for TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS, Substantially Equivalent on 2012-02-03. Applicant: Teratech Corp..

Clearance details

Applicant: Teratech Corp.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2011-10-04
Decision date: 2012-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.