TraumaCad Mobile Release 2.0— 510(k) K160001

Substantially Equivalent

Voyant Health, Ltd.

FDA 510(k) clearance K160001 for TraumaCad Mobile Release 2.0, Substantially Equivalent on 2016-02-12. Applicant: Voyant Health, Ltd..

Clearance details

Applicant: Voyant Health, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-01-04
Decision date: 2016-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Petach-Tikva, IL

Download summary PDF View on FDA.gov ↗

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.