Patient Positioning System

FDA 510(k) K170502 · Forte Automation Systems, Inc.

Substantially Equivalent

510(k) numberK170502

Submission

Device name
Patient Positioning System
Applicant
Forte Automation Systems, Inc.
Machesney Park, IL, US
Received
February 21, 2017
Decision date
April 13, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JAI – Couch, Radiation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5770
Specialty
Radiology

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Questions and answers

When was Patient Positioning System cleared by the FDA?

Patient Positioning System (K170502) received a 510(k) decision of Substantially Equivalent on April 13, 2017, 51 days after the submission was received.

What is the product code of K170502?

The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.