Cleared Traditional

K230016 - Cercare Medical Neurosuite (FDA 510(k) Clearance)

K230016 · Cercare Medical A/S · Radiology device

Jul 2023

Decision

192d

Days

Class 2

Risk

K230016 is an FDA 510(k) clearance for the Cercare Medical Neurosuite. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Cercare Medical A/S (Aarhus, DK). The FDA issued a Cleared decision on July 14, 2023, 192 days after receiving the submission on January 3, 2023.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K230016 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 03, 2023
Decision Date	July 14, 2023
Days to Decision	192 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF