GENESIS— 510(k) K122768

Substantially Equivalent

Dornier Medtech America, Inc.

FDA 510(k) clearance K122768 for GENESIS, Substantially Equivalent on 2013-01-18. Applicant: Dornier Medtech America, Inc..

Clearance details

Applicant: Dornier Medtech America, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 2012-09-10
Decision date: 2013-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.