MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001— 510(k) K053325

Substantially Equivalent

Mediwatch, Ltd.

FDA 510(k) clearance K053325 for MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001, Substantially Equivalent on 2005-12-07. Applicant: Mediwatch, Ltd..

Clearance details

Applicant: Mediwatch, Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2005-12-01
Decision date: 2005-12-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Warwickshire, GB

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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.