MRI PATIENT POSITIONING DEVICES— 510(k) K080072

Substantially Equivalent

CIVCO Medical Instruments Co., Inc.

FDA 510(k) clearance K080072 for MRI PATIENT POSITIONING DEVICES, Substantially Equivalent on 2008-06-04. Applicant: CIVCO Medical Instruments Co., Inc..

Clearance details

Applicant: CIVCO Medical Instruments Co., Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2008-01-11
Decision date: 2008-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, 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.