FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AI-Rad Companion Brain MR
K Number: K213706
·
Decision Apr 15, 2022
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
31
Review Days
142
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Basic Information
- Device Name
- AI-Rad Companion Brain MR
- K Number
- K213706
- 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
- November 24, 2021
- Decision Date
- April 15, 2022
- 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 | ||
|---|---|---|---|
| K253264 | myAblation Guide (VC10A) | Jun 16, 2026 | Substantially Equivalent |
| K253689 | syngo Dynamics (VA41F) | Apr 10, 2026 | Substantially Equivalent |
| K252548 | AI-Rad Companion Organs RT | Apr 10, 2026 | Substantially Equivalent |
| K253057 | AI-Rad Companion Brain MR | Jan 22, 2026 | Substantially Equivalent |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | Dec 19, 2025 | Substantially Equivalent |
| 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 |