The following data is part of a premarket notification filed by Radiation Technology, Inc. with the FDA for Therapy Chair System.
| Device ID | K910648 |
| 510k Number | K910648 |
| Device Name: | THERAPY CHAIR SYSTEM |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | RADIATION TECHNOLOGY, INC. 16 PEDLEY ST., WAVELL HEIGHTS Brisbane, Queensland, AU Qld 4012 |
| Contact | M. A Rose |
| Correspondent | M. A Rose RADIATION TECHNOLOGY, INC. 16 PEDLEY ST., WAVELL HEIGHTS Brisbane, Queensland, AU Qld 4012 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-14 |
| Decision Date | 1991-07-22 |