QuantX Breast MRI Biopsy Guidance Plugin— 510(k) K191959

Substantially Equivalent

Qlarity Imaging

FDA 510(k) clearance K191959 for QuantX Breast MRI Biopsy Guidance Plugin, Substantially Equivalent on 2019-11-08. Applicant: Qlarity Imaging.

Clearance details

Applicant: Qlarity Imaging
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2019-07-23
Decision date: 2019-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.