Symbia 6.7— 510(k) K200474
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K200474 for Symbia 6.7, Substantially Equivalent on 2020-03-20. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- 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
- Hoffman Estates, IL, US
Recent devices under product code KPS
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K200474
K-number listed on FDA's recall record- Z-0893-2022 — Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
- Z-2934-2020 — Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200474.
Data sourced from openFDA. This site is unofficial and independent of the FDA.