Cleared Traditional

K122413 - PATIENT POSITIONING SYSTEM
(FDA 510(k) Clearance)

K122413 · Forte Automation Systems, Inc. · Radiology

Sep 2012

Decision

36d

Days

Class 2

Risk

K122413 is an FDA 510(k) clearance for the PATIENT POSITIONING SYSTEM. This device is classified as a Couch, Radiation Therapy, Powered (Class II — Special Controls, product code JAI).

Submitted by Forte Automation Systems, Inc. (Machesney Park, US). The FDA issued a Cleared decision on September 13, 2012, 36 days after receiving the submission on August 8, 2012.

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

Submission Details

510(k) Number	K122413 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2012
Decision Date	September 13, 2012
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF