Cleared Traditional

QUIBIM Precision Prostate (qp-Prostate)

K203582 · Quibim S.L. · Radiology

Feb 2021

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K203582 is an FDA 510(k) clearance for the QUIBIM Precision Prostate (qp-Prostate), a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Quibim S.L. (Valencia, ES). The FDA issued a Cleared decision on February 4, 2021, 59 days after receiving the submission on December 7, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K203582 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 07, 2020
Decision Date	February 04, 2021
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF