AI-Rad Companion Organs RT— 510(k) K242745

Name: FDA 510(k) clearance K242745
Creator: U.S. Food and Drug Administration
Published: 2025-03-27

Substantially Equivalent

Siemens Healthcare GmbH

FDA 510(k) clearance K242745 for AI-Rad Companion Organs RT, Substantially Equivalent on 2025-03-27. Applicant: Siemens Healthcare GmbH. Device class: 2.

Clearance details

Applicant: Siemens Healthcare GmbH
Product code: Code QKB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-09-11
Decision date: 2025-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erlangen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QKB

view all

K262452 — AutoContour (RADAC V6)2026-08-14
K261306 — AI Contouring (VA10A)2026-07-10
K260528 — OncoStudio2026-07-02
K252190 — DeepBT Detector-Plus2026-04-10
K252548 — AI-Rad Companion Organs RT2026-04-10

More clearances from Siemens Healthcare GmbH

view all

K253264 — myAblation Guide (VC10A)2026-06-16
K253689 — syngo Dynamics (VA41F)2026-04-10
K253057 — AI-Rad Companion Brain MR2026-01-22
K252838 — MAGNETOM Sola +9 more2025-12-19
K252608 — AI-Rad Companion Prostate MR2025-09-09

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