TELEVIX— 510(k) K790692

Substantially Equivalent

General Electrical Espanola, S.A.

FDA 510(k) clearance K790692 for TELEVIX, Substantially Equivalent on 1979-04-23. Applicant: General Electrical Espanola, S.A.. Device class: 2.

Clearance details

Applicant: General Electrical Espanola, S.A.
Product code: Code KXJ
Device class: Class 2
Regulation: 21 CFR 892.1980
Advisory panel: Radiology
Date received: 1979-04-10
Decision date: 1979-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXJ

K050190 — APOLLO2005-03-25
K963905 — RADIOGRAPHIC ITT TABLE1996-11-12
K955414 — XRT 4001996-07-24
K951146 — IMAGING TABLE1995-05-04
K950068 — CARBON FIBER COUCH INSERT1995-04-06

Recalls naming K790692

K-number listed on FDA's recall record

Z-1753-2019 — Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.Class II·Terminated·GE Healthcare, LLC·20190329

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K790692.

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