PORTASCAN BLADDER SCANNER, MODEL PA00146— 510(k) K033906

Substantially Equivalent

Mediwatch Plc

FDA 510(k) clearance K033906 for PORTASCAN BLADDER SCANNER, MODEL PA00146, Substantially Equivalent on 2003-12-24. Applicant: Mediwatch Plc.

Clearance details

Applicant: Mediwatch Plc
Product code: Code IYO
Advisory panel: Radiology
Date received: 2003-12-17
Decision date: 2003-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rugby, 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.