0180 INTUITION, 0072 PRECISION— 510(k) K140683

Substantially Equivalent

Arcoma AB

FDA 510(k) clearance K140683 for 0180 INTUITION, 0072 PRECISION, Substantially Equivalent on 2014-06-03. Applicant: Arcoma AB.

Clearance details

Applicant: Arcoma AB
Product code: Code KPR
Advisory panel: Radiology
Date received: 2014-03-18
Decision date: 2014-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.