Symbia Pro.specta Q3 (11364751)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K261315 FDA 510(k)
- FDA Product Code
- KPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1200 FDA 510(k)
- Regulation Number
- 892.1200 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Symbia Pro.specta Q3 is a SPECT/CT imaging system used for nuclear medicine procedures. It combines single-photon emission computed tomography with computed tomography to provide detailed images of the body's internal structures and functions.
This device is manufactured by Siemens Medical Solutions USA, Inc. and is FDA 510(k) cleared under product code KPS for radiology applications. The system is supplied in various models including Q3, X3, X7, and VA40 Family configurations, with specific model numbers retained for identification.
Frequently asked questions
What is the Symbia Pro.specta Q3 used for?
The Symbia Pro.specta Q3 is a SPECT/CT imaging system used for nuclear medicine procedures. It combines single-photon emission computed tomography with computed tomography to provide detailed images of the body's internal structures and functions.
What models are available in the Symbia Pro.specta series?
The Symbia Pro.specta series includes various models including Q3, X3, X7, and VA40 Family configurations, with specific model numbers retained for identification. Each model offers different specifications to meet various clinical needs.
What is the regulatory status of the Symbia Pro.specta Q3?
The Symbia Pro.specta Q3 is FDA 510(k) cleared under product code KPS for radiology applications. It has been determined to be substantially equivalent to predicate devices in this category.
Who manufactures the Symbia Pro.specta Q3?
The Symbia Pro.specta Q3 is manufactured by Siemens Medical Solutions USA, Inc., a leading provider of medical imaging equipment and solutions. The company is headquartered in Knoxville, Tennessee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Symbia Pro.specta SPECT/CT - Siemens Healthineers, Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752 ..., Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752 ..., Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K261315 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Medical Solutions Usa, Inc.
Sources (1)
- FDA 510(k) K261315-1 24 fields · synced Sep 22, 2026