Symbia SPECT and SPECT/CT Systems— 510(k) K241898

Name: FDA 510(k) clearance K241898
Creator: U.S. Food and Drug Administration
Published: 2024-07-26

Substantially Equivalent

Siemens Healthineers

FDA 510(k) clearance K241898 for Symbia SPECT and SPECT/CT Systems, Substantially Equivalent on 2024-07-26. Applicant: Siemens Healthineers. Device class: 2.

Clearance details

Applicant: Siemens Healthineers
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2024-06-28
Decision date: 2024-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

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