Cleared Traditional

K132084 - PROTURA COUCH SOFTWARE
(FDA 510(k) Clearance)

K132084 · Med-Tec, Inc. D/B/A Civco Medical Solutions · Radiology

Sep 2013

Decision

83d

Days

Class 2

Risk

K132084 is an FDA 510(k) clearance for the PROTURA COUCH SOFTWARE. This device is classified as a Couch, Radiation Therapy, Powered (Class II — Special Controls, product code JAI).

Submitted by Med-Tec, Inc. D/B/A Civco Medical Solutions (Orange City, US). The FDA issued a Cleared decision on September 26, 2013, 83 days after receiving the submission on July 5, 2013.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5770.

Submission Details

510(k) Number	K132084 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2013
Decision Date	September 26, 2013
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF