The following data is part of a premarket notification filed by Elekta, Inc. with the FDA for Monaco Rtp System.
| Device ID | K190178 |
| 510k Number | K190178 |
| Device Name: | Monaco RTP System |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Elekta, Inc. 13723 Riverport Drive, Suite 100 Maryland Heights, MO 63043 |
| Contact | Kathryn Stinson |
| Correspondent | Kathryn Stinson Elekta, Inc. 13723 Riverport Drive, Suite 100 Maryland Heights, MO 63043 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858164002268 | K190178 | 000 |
| 00858164002275 | K190178 | 000 |