Cleared Traditional

.DECIMAL PHOTON BLOCK

K123015 · .Decimal, Inc. · Radiology
Nov 2012
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K123015 is an FDA 510(k) clearance for the .DECIMAL PHOTON BLOCK, a Block, Beam-shaping, Radiation Therapy (Class II — Special Controls, product code IXI), submitted by .Decimal, Inc. (Sanford, US). The FDA issued a Cleared decision on November 21, 2012, 54 days after receiving the submission on September 28, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5710.

Submission Details

510(k) Number K123015 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2012
Decision Date November 21, 2012
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXI — Block, Beam-shaping, Radiation Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5710