DCM 1.0— 510(k) K011246

Substantially Equivalent

Mds Nordion

FDA 510(k) clearance K011246 for DCM 1.0, Substantially Equivalent on 2001-05-23. Applicant: Mds Nordion. Device class: 2.

Clearance details

Applicant: Mds Nordion
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2001-04-23
Decision date: 2001-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUJ

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 Mds Nordion

K060870 — AVANZA2006-05-15
K051065 — RAYCELL X-RAY BLOOD IRRADIATOR2005-05-26
K050963 — GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN2005-05-20
K032684 — RAYCELL2003-09-26
K010682 — HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM2001-06-05

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