MedDream— 510(k) K162011

Substantially Equivalent

Softneta Uab

FDA 510(k) clearance K162011 for MedDream, Substantially Equivalent on 2016-10-14. Applicant: Softneta Uab.

Clearance details

Applicant: Softneta Uab
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-07-21
Decision date: 2016-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaunas, LT

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.