Cleared Special

K010784 - PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
(FDA 510(k) Clearance)

K010784 · Nucletron Corp. · Radiology
Apr 2001
Decision
26d
Days
Class 2
Risk

K010784 is an FDA 510(k) clearance for the PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on April 10, 2001, 26 days after receiving the submission on March 15, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K010784 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2001
Decision Date April 10, 2001
Days to Decision 26 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