FDA-cleared K242683

QP-Prostate® CAD

Quibim S.L.

QP-Prostate CAD detects and marks suspected prostate lesions for clinically significant prostate cancer on bi-parametric T2-weighted and diffusion-weighted prostate MRI, returning...

Modality
MRI
Anatomy
Prostate
Decision
2025-03-18
FDA-cleared K232231

QP-Brain®

Quibim S.L.

Automatically label and volumetrically quantify segmentable brain structures and white matter hyperintensities (WMH) from MR images in adults and adolescents aged 18 years and...

Modality
MRI
Anatomy
Brain
Decision
2023-12-13
FDA-cleared K203582

QUIBIM Precision Prostate (qp-Prostate)

QUIBIM S.L.

qp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The...

Modality
MRI
Anatomy
Prostate
Decision
2021-02-04