Cleared Special

K170502 - Patient Positioning System
(FDA 510(k) Clearance)

K170502 · Forte Automation Systems, Inc. · Radiology

Apr 2017

Decision

51d

Days

Class 2

Risk

K170502 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 April 13, 2017, 51 days after receiving the submission on February 21, 2017.

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

Submission Details

510(k) Number	K170502 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2017
Decision Date	April 13, 2017
Days to Decision	51 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Statement