REMOTEYE VIEWER— 510(k) K141061

Substantially Equivalent

Neologica S.R.L.

FDA 510(k) clearance K141061 for REMOTEYE VIEWER, Substantially Equivalent on 2014-08-01. Applicant: Neologica S.R.L..

Clearance details

Applicant: Neologica S.R.L.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-04-24
Decision date: 2014-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cairo Montenotte (Sv), IT

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.