Cleared Traditional

.DECIMAL PROTON APERTURE

K132236 · .Decimal, Inc. · Radiology

Oct 2013

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K132236 is an FDA 510(k) clearance for the .DECIMAL PROTON 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 October 16, 2013, 90 days after receiving the submission on July 18, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5710.

Submission Details

510(k) Number	K132236 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2013
Decision Date	October 16, 2013
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF