Cleared Special

K031349 - OTP 1.2
(FDA 510(k) Clearance)

K031349 · Nucletron Corp. · Radiology
Aug 2003
Decision
100d
Days
Class 2
Risk

K031349 is an FDA 510(k) clearance for the OTP 1.2. This device is classified as 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 August 7, 2003, 100 days after receiving the submission on April 29, 2003.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K031349 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2003
Decision Date August 07, 2003
Days to Decision 100 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