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 |