ERGO++ VERSION 1.7— 510(k) K080601

Name: FDA 510(k) clearance K080601
Creator: U.S. Food and Drug Administration
Published: 2008-06-06

Substantially Equivalent

3D Line Medical Systems S.R.L.

FDA 510(k) clearance K080601 for ERGO++ VERSION 1.7, Substantially Equivalent on 2008-06-06. Applicant: 3D Line Medical Systems S.R.L.. Device class: 2.

Clearance details

Applicant: 3D Line Medical Systems S.R.L.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2008-03-03
Decision date: 2008-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K080601

K-number listed on FDA's recall record

Z-0234-2018 — Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.Class II·Terminated·Elekta Inc·20170901

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080601.

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