VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER— 510(k) K122236

Clearance details

Applicant

Varian Medical Systems, Inc.

Product code

Code JAQ

Device class

Class 2

Regulation

21 CFR 892.5700

Advisory panel

Radiology

Date received

2012-07-26

Decision date

2012-11-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Palo Alto, CA, US

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• Z-1849-2015 — The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.Class II·Terminated·Varian Medical Systems Inc·20150518

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122236.