Cleared Traditional

K223048 - Medisystem Pacs (FDA 510(k) Clearance)

K223048 · Medilab Manutencao E Sitemas Ltda · Radiology device

Jun 2023

Decision

267d

Days

Class 2

Risk

K223048 is an FDA 510(k) clearance for the Medisystem Pacs. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Medilab Manutencao E Sitemas Ltda (Rio De Janeiro, BR). The FDA issued a Cleared decision on June 23, 2023, 267 days after receiving the submission on September 29, 2022.

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

Submission Details

510(k) Number	K223048 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 29, 2022
Decision Date	June 23, 2023
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF