VENTRI— 510(k) K051855

Substantially Equivalent

Ge Medical Systems F.I. Haifa

FDA 510(k) clearance K051855 for VENTRI, Substantially Equivalent on 2005-08-02. 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: 2005-07-08
Decision date: 2005-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

Download summary PDF View on FDA.gov ↗

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K083504 — GE DISCOVERY NM/CT 570C2008-12-12
K080124 — VENTRI 1.12008-01-31

Recalls naming K051855

K-number listed on FDA's recall record

Z-2258-2020 — System, Tomography Computed EmmissionClass II·Ongoing·GE Healthcare, LLC·20181130
Z-1168-2013 — Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.Class II·Terminated·GE Healthcare, LLC·20130109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051855.

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