Cleared Special

SPOT PRO (220V), MODEL 131.099

K022741 · Nucletron Corporation · Radiology
Oct 2002
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K022741 is an FDA 510(k) clearance for the SPOT PRO (220V), MODEL 131.099, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on October 24, 2002, 66 days after receiving the submission on August 19, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K022741 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2002
Decision Date October 24, 2002
Days to Decision 66 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050