POSICAST IMMOBILIZATION SYSTEM— 510(k) K926187

Substantially Equivalent

Huestis Machine Corp.

FDA 510(k) clearance K926187 for POSICAST IMMOBILIZATION SYSTEM, Substantially Equivalent on 1994-04-15. Applicant: Huestis Machine Corp..

Clearance details

Applicant: Huestis Machine Corp.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1992-12-08
Decision date: 1994-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bristol, RI, US

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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.