ONCO TRAC MODEL 1, 2, 4— 510(k) K111642

Substantially Equivalent

Translational Sciences Corporation

FDA 510(k) clearance K111642 for ONCO TRAC MODEL 1, 2, 4, Substantially Equivalent on 2011-11-18. Applicant: Translational Sciences Corporation.

Clearance details

Applicant: Translational Sciences Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2011-06-13
Decision date: 2011-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.