PET Digital Gating— 510(k) K180318

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K180318 for PET Digital Gating, Substantially Equivalent on 2018-04-11. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2018-02-05
Decision date: 2018-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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