BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST— 510(k) K081218

Substantially Equivalent

It-V Medizintechnik, GmbH

FDA 510(k) clearance K081218 for BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST, Substantially Equivalent on 2008-07-21. Applicant: It-V Medizintechnik, GmbH.

Clearance details

Applicant: It-V Medizintechnik, GmbH
Product code: Code IYE
Advisory panel: Radiology
Date received: 2008-04-30
Decision date: 2008-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

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.