AI-Rad Companion Organs RT
FDA 510(k) K242745 · Siemens Healthcare GmbH
510(k) numberK242745
Submission
- Device name
- AI-Rad Companion Organs RT
- Applicant
- Siemens Healthcare GmbH
Erlangen, DE - Received
- September 11, 2024
- Decision date
- March 27, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QKB – Radiological Image Processing Software For Radiation Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image…
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Questions and answers
When was AI-Rad Companion Organs RT cleared by the FDA?
AI-Rad Companion Organs RT (K242745) received a 510(k) decision of Substantially Equivalent on March 27, 2025, 197 days after the submission was received.
What is the product code of K242745?
The FDA product code is QKB – Radiological Image Processing Software For Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.2050.