Nucleus.io— 510(k) K203249

Substantially Equivalent

Nucleushealth, LLC

FDA 510(k) clearance K203249 for Nucleus.io, Substantially Equivalent on 2020-12-04. Applicant: Nucleushealth, LLC.

Clearance details

Applicant: Nucleushealth, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-11-04
Decision date: 2020-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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.