The following data is part of a premarket notification filed by Forte Automation Systems, Inc. with the FDA for Patient Positioning System.
Device ID | K122413 |
510k Number | K122413 |
Device Name: | PATIENT POSITIONING SYSTEM |
Classification | Couch, Radiation Therapy, Powered |
Applicant | FORTE AUTOMATION SYSTEMS, INC. 8155 Burden Rd Machesney Park, IL 61115 |
Contact | Phil Reece |
Correspondent | Phil Reece FORTE AUTOMATION SYSTEMS, INC. 8155 Burden Rd Machesney Park, IL 61115 |
Product Code | JAI |
CFR Regulation Number | 892.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-08 |
Decision Date | 2012-09-13 |
Summary: | summary |