Cleared Traditional

ITP, MODEL 1.0

K992434 · Nucletron Corp. · Radiology
Jan 2000
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K992434 is an FDA 510(k) clearance for the ITP, MODEL 1.0, 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 January 13, 2000, 176 days after receiving the submission on July 21, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K992434 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1999
Decision Date January 13, 2000
Days to Decision 176 days
Submission Type Traditional
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