Cleared Traditional

P.D SOFTWARE

K083672 · .Decimal, Inc. · Radiology
Apr 2009
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K083672 is an FDA 510(k) clearance for the P.D SOFTWARE, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by .Decimal, Inc. (Sanford, US). The FDA issued a Cleared decision on April 13, 2009, 123 days after receiving the submission on December 11, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K083672 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2008
Decision Date April 13, 2009
Days to Decision 123 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