ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032— 510(k) K071673

Substantially Equivalent

Onc Solutions, Inc.

FDA 510(k) clearance K071673 for ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032, Substantially Equivalent on 2007-07-18. Applicant: Onc Solutions, Inc..

Clearance details

Applicant: Onc Solutions, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2007-06-19
Decision date: 2007-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, 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.