QuantorView— 510(k) K151687

Substantially Equivalent

3Disc Americas

FDA 510(k) clearance K151687 for QuantorView, Substantially Equivalent on 2015-08-03. Applicant: 3Disc Americas.

Clearance details

Applicant: 3Disc Americas
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2015-06-23
Decision date: 2015-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling, VA, 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.