FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
syngo Dynamics (VA41F)
K Number: K253689
·
Decision Apr 10, 2026
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
31
Review Days
140
Basic Information
- Device Name
- syngo Dynamics (VA41F)
- K Number
- K253689
- 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 21, 2025
- Decision Date
- April 10, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QIH), ordered by most recent decision date.
Synapse PACS (7.6.0)
FDA 510(k)
FDA Class 2
·Radiology
WatchMate Software
FDA 510(k)
FDA Class 2
·Radiology
MediAI-OA
FDA 510(k)
FDA Class 2
·Radiology
LungMaps
FDA 510(k)
FDA Class 2
·Radiology
Brainomix 360 Hyperdensity
FDA 510(k)
FDA Class 2
·Radiology
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Siemens Healthcare GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K253264 | myAblation Guide (VC10A) | Jun 16, 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 |
| K240796 | myAblation Guide (VB80A) | Aug 6, 2024 | Substantially Equivalent |