syngo Application Software— 510(k) K254184
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K254184 for syngo Application Software, Substantially Equivalent on 2026-04-29. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
Siemens Medical Solutions USA's syngo Application Software is filed under product code QIH (Automated Radiological Image Processing Software). The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Siemens Medical Solutions USA filed from Malvern, Pennsylvania. The decision came 127 calendar days after FDA received it (December 23, 2025 to April 29, 2026).
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code QIH
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