CHABNER XRT GARMENTS— 510(k) K121284

Substantially Equivalent

Chabner Xrt, LLC

FDA 510(k) clearance K121284 for CHABNER XRT GARMENTS, Substantially Equivalent on 2013-06-14. Applicant: Chabner Xrt, LLC.

Clearance details

Applicant: Chabner Xrt, LLC
Product code: Code IYE
Advisory panel: Radiology
Date received: 2012-04-30
Decision date: 2013-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Chester, NY, 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.