P-ART, MODEL 001— 510(k) K092424

Substantially Equivalent

P-Cure, Ltd.

FDA 510(k) clearance K092424 for P-ART, MODEL 001, Substantially Equivalent on 2010-03-05. Applicant: P-Cure, Ltd..

Clearance details

Applicant: P-Cure, Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2009-08-07
Decision date: 2010-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, Hasharon, IL

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.