Cleared Special

LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM

K132874 · Nucletron B.V. · Radiology

Feb 2014

Decision

161d

Days

Class 2

Risk

About This 510(k) Submission

K132874 is an FDA 510(k) clearance for the LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron B.V. (Veenendaal, NL). The FDA issued a Cleared decision on February 21, 2014, 161 days after receiving the submission on September 13, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number	K132874 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2013
Decision Date	February 21, 2014
Days to Decision	161 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF