The following data is part of a premarket notification filed by Forte Automation Systems, Inc. with the FDA for Patient Positioning System.
Device ID | K170502 |
510k Number | K170502 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-21 |
Decision Date | 2017-04-13 |