syngo.CT Brain Quantification— 510(k) K260055
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K260055 for syngo.CT Brain Quantification, Substantially Equivalent on 2026-09-25. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
syngo.CT Brain Quantification is Siemens software filed under QIH, automated radiological image processing software. The name says it quantifies something on brain CT; the record doesn't specify what it measures.
Class II, 21 CFR 892.2050, Radiology panel, Traditional 510(k).
Siemens Medical Solutions USA, Inc. filed from Knoxville, Tennessee. Review took 260 days (January 8 to September 25, 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
- Knoxville, TN, US
Recent devices under product code QIH
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