GE DISCOVERY ST— 510(k) K041543

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K041543 for GE DISCOVERY ST, Substantially Equivalent on 2004-06-22. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2004-06-08
Decision date: 2004-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K041543

K-number listed on FDA's recall record

Z-2803-2015 — PET Discovery ST 16Class II·Terminated·GE Healthcare·20150717

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041543.

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