Symbia Pro.specta Q3 (11364751) +3 more— 510(k) K261315
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K261315 for Symbia Pro.specta Q3 (11364751) +3 more, Substantially Equivalent on 2026-05-21. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
Siemens Medical Solutions USA's record lists the Symbia Pro.specta Q3 (11364751), X3 (11364752) and X7 (11364753), plus the Symbia Pro.specta VA40 Family. The product code is KPS, computed emission tomography systems.
Class II, 21 CFR 892.1200. Radiology is both the classification panel and the review panel. It came in as a Special 510(k).
Siemens filed from Knoxville, Tennessee. The decision came 30 calendar days after receipt (April 21 to May 21, 2026).
Clearance details
- Device name as filed
- Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Product code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Knoxville, TN, US
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