DIGI-LITE TCD DEVICE— 510(k) K062578

Substantially Equivalent

Rimed , Ltd.

FDA 510(k) clearance K062578 for DIGI-LITE TCD DEVICE, Substantially Equivalent on 2006-09-18. Applicant: Rimed , Ltd..

Clearance details

Applicant: Rimed , Ltd.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2006-08-31
Decision date: 2006-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.