SIEMENS ENHANCED IMAGING SYSTEM— 510(k) K041166
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K041166 for SIEMENS ENHANCED IMAGING SYSTEM, Substantially Equivalent on 2004-05-17. 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
- Traditional
- Location
- Hoffman Estates, IL, US
Recent devices under product code KPS
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K041166
K-number listed on FDA's recall record- Z-0061-2017 — Symbia S, Product Usage 1) 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 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy. .
- Z-1086-2015 — The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041166.
Data sourced from openFDA. This site is unofficial and independent of the FDA.