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K Number
K170502
Device Name
Patient Positioning System
Manufacturer
Forte Automation Systems, Inc.
Date Cleared
2017-04-13

(51 days)

Product Code
JAI
Regulation Number
892.5770
Type
Special
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The patient positioning system is a SCARA designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for a device called "Patient Positioning System" by Forte Automation Systems, Inc. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide a response to your request, as the necessary information is not present in the provided text.

§ 892.5770 Powered radiation therapy patient support assembly.

(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.