Patient Positioning System

Couch, Radiation Therapy, Powered

Forte Automation Systems, Inc.

The following data is part of a premarket notification filed by Forte Automation Systems, Inc. with the FDA for Patient Positioning System.

Pre-market Notification Details

Device IDK170502
510k NumberK170502
Device Name:Patient Positioning System
ClassificationCouch, Radiation Therapy, Powered
Applicant Forte Automation Systems, Inc. 8155 Burden Rd Machesney Park,  IL  61115
ContactPhil Reece
CorrespondentPhil Reece
Forte Automation Systems, Inc. 8155 Burden Rd Machesney Park,  IL  61115
Product CodeJAI  
CFR Regulation Number892.5770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-21
Decision Date2017-04-13

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