MRCAT Pelvis— 510(k) K182888

Name: FDA 510(k) clearance K182888
Creator: U.S. Food and Drug Administration
Published: 2019-04-30

Substantially Equivalent

Philips Medical Systems MR Finland

FDA 510(k) clearance K182888 for MRCAT Pelvis, Substantially Equivalent on 2019-04-30. Applicant: Philips Medical Systems MR Finland. Device class: 2.

Clearance details

Applicant: Philips Medical Systems MR Finland
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2018-10-15
Decision date: 2019-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vantaa, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUJ

view all

K260750 — Virtual Cone (1.0)2026-07-08
K253050 — RadOncAI2026-06-18
K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)2026-05-27
K252784 — eXaSkin Plus2026-05-22
K253078 — ART.1-US2026-05-14

More clearances from Philips Medical Systems MR Finland

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.