MARK V DUPLEX ULTRASONIC SCAN SYS.— 510(k) K802438

Substantially Equivalent

Advanced Technology Laboratories, Inc.

FDA 510(k) clearance K802438 for MARK V DUPLEX ULTRASONIC SCAN SYS., Substantially Equivalent on 1981-01-21. Applicant: Advanced Technology Laboratories, Inc..

Clearance details

Applicant: Advanced Technology Laboratories, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1980-10-06
Decision date: 1981-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.