Cleared Traditional

SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0

K992303 · Nucletron Corp. · Radiology
Mar 2000
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K992303 is an FDA 510(k) clearance for the SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 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 March 27, 2000, 263 days after receiving the submission on July 8, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K992303 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1999
Decision Date March 27, 2000
Days to Decision 263 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