Cleared Traditional

.DECIMAL APERTURE

K071077 · .Decimal, Inc. · Radiology
May 2007
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K071077 is an FDA 510(k) clearance for the .DECIMAL APERTURE, 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 May 18, 2007, 31 days after receiving the submission on April 17, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5710.

Submission Details

510(k) Number K071077 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2007
Decision Date May 18, 2007
Days to Decision 31 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