QUIBIM Precision Prostate (qp-Prostate)— 510(k) K203582

Name: FDA 510(k) clearance K203582
Creator: U.S. Food and Drug Administration
Published: 2021-02-04

Substantially Equivalent

Quibim S.L.

FDA 510(k) clearance K203582 for QUIBIM Precision Prostate (qp-Prostate), Substantially Equivalent on 2021-02-04. Applicant: Quibim S.L.. Device class: 2.

Clearance details

Applicant: Quibim S.L.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-12-07
Decision date: 2021-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Quibim S.L.

view all

K242683 — QP-Prostate® CAD2025-03-18
K232231 — QP-Brain®2023-12-13

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.