AI-Rad Companion Organs RT— 510(k) K252548
Substantially EquivalentSiemens Healthcare GmbH
FDA 510(k) clearance K252548 for AI-Rad Companion Organs RT, Substantially Equivalent on 2026-04-10. Applicant: Siemens Healthcare GmbH. Device class: 2.
Summary
AI-Rad Companion Organs RT is filed under QKB, radiological image processing software for radiation therapy. The code covers AI-based image processing and analysis tools used in the radiation therapy workflow. The record doesn't describe what this software does beyond that product code.
Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).
Siemens Healthcare GmbH filed from Erlangen, Germany. Review took 240 days (August 13, 2025 to April 10, 2026).
Clearance details
- Applicant
- Siemens Healthcare GmbH
- Product code
- Product code QKB
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Erlangen, DE
Recent devices under product code QKB
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