PATHFINDER MOBILE C ARM— 510(k) K981131

Substantially Equivalent

Acoma Medical Imaging, Inc.

FDA 510(k) clearance K981131 for PATHFINDER MOBILE C ARM, Substantially Equivalent on 1998-06-26. Applicant: Acoma Medical Imaging, Inc..

Clearance details

Applicant: Acoma Medical Imaging, Inc.
Product code: Code OXO
Advisory panel: Radiology
Date received: 1998-03-30
Decision date: 1998-06-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wheeling, IL, US

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.