SYMBIA-E, MODEL 10275879— 510(k) K072567

Name: FDA 510(k) clearance K072567
Creator: U.S. Food and Drug Administration
Published: 2007-10-30

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K072567 for SYMBIA-E, MODEL 10275879, Substantially Equivalent on 2007-10-30. 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: 2007-09-12
Decision date: 2007-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Hoffman Estates, IL, US

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Recalls naming K072567

K-number listed on FDA's recall record

Z-1296-2015 — Symbia E is a multi-purpose SPECT system used 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.Class II·Terminated·Siemens Medical Solutions USA, Inc.·20120411

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072567.

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Clearance details

Recent devices under product code KPS

More clearances from Siemens Medical Solutions USA, Inc.

Recalls naming K072567