The following data is part of a premarket notification filed by Siemens Medical Laboratories, Inc. with the FDA for Z Xt Radiation Therapy Treatment Table.
| Device ID | K910971 |
| 510k Number | K910971 |
| Device Name: | Z XT RADIATION THERAPY TREATMENT TABLE |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | SIEMENS MEDICAL LABORATORIES, INC. 4040 NELSON AVE. Concord, CA 94520 |
| Contact | Morton, Jr |
| Correspondent | Morton, Jr SIEMENS MEDICAL LABORATORIES, INC. 4040 NELSON AVE. Concord, CA 94520 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-07 |
| Decision Date | 1991-05-03 |