FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
AI-Rad Companion Brain MR
K Number: K253057
·
Decision Jan 22, 2026
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
31
Review Days
122
Basic Information
- Device Name
- AI-Rad Companion Brain MR
- K Number
- K253057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare GmbH
- Date Received
- September 22, 2025
- Decision Date
- January 22, 2026
- Product Code
- QIH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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Other Clearances by Siemens Healthcare GmbH
| K Number | Device Name | ||
|---|---|---|---|
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| K252548 | AI-Rad Companion Organs RT | Apr 10, 2026 | Substantially Equivalent |
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| K252608 | AI-Rad Companion Prostate MR | Sep 9, 2025 | Substantially Equivalent |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | Jun 16, 2025 | Substantially Equivalent |
| K242551 | syngo Dynamics (Version VA41D) | Apr 3, 2025 | Substantially Equivalent |
| K242745 | AI-Rad Companion Organs RT | Mar 27, 2025 | Substantially Equivalent |
| K241770 | Prostate MR AI (VA10A) | Mar 5, 2025 | Substantially Equivalent |
| K240796 | myAblation Guide (VB80A) | Aug 6, 2024 | Substantially Equivalent |