GE DISCOVERY NM/CT 570C— 510(k) K083504

Name: FDA 510(k) clearance K083504
Creator: U.S. Food and Drug Administration
Published: 2008-12-12

Substantially Equivalent

Ge Medical Systems F.I. Haifa

FDA 510(k) clearance K083504 for GE DISCOVERY NM/CT 570C, Substantially Equivalent on 2008-12-12. Applicant: Ge Medical Systems F.I. Haifa. Device class: 2.

Clearance details

Applicant: Ge Medical Systems F.I. Haifa
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2008-11-26
Decision date: 2008-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

view all

K261305 — MICSI-PET2026-09-11
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
K261315 — Symbia Pro.specta Q3 (11364751) +3 more2026-05-21
K260524 — uMI Panvivo (5 models)2026-04-03
K253564 — uMI Panvivo (4 models)2026-02-13

More clearances from Ge Medical Systems F.I. Haifa

view all

K130884 — XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION2013-04-12
K093982 — XELERIS 3 PROCESSING AND REVIEW WORKSTATION2010-01-08
K093514 — DISCOVERY MODEL NM/CT 6702009-12-10
K080124 — VENTRI 1.12008-01-31
K051855 — VENTRI2005-08-02

Recalls naming K083504

K-number listed on FDA's recall record

Z-2196-2017 — GE Healthcare Discovery NM/CT 570c X-ray systemClass II·Terminated·GE Healthcare, LLC·20170519

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083504.

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