ECHO-SCAN— 510(k) K941322

Name: FDA 510(k) clearance K941322
Creator: U.S. Food and Drug Administration
Published: 1995-07-27

Substantially Equivalent

Tomographic Tech

FDA 510(k) clearance K941322 for ECHO-SCAN, Substantially Equivalent on 1995-07-27. Applicant: Tomographic Tech. Device class: 2.

Clearance details

Applicant: Tomographic Tech
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1994-03-18
Decision date: 1995-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.