RayStation
GUDID 07350002010129
Raysearch Laboratories AB (Publ)
Radiation therapy software| Primary Device ID | 07350002010129 |
| NIH Device Record Key | 298a4be3-acc9-4468-9688-e651f72b620b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RayStation |
| Version Model Number | 8.1 |
| Company DUNS | 355977901 |
| Company Name | Raysearch Laboratories AB (Publ) |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350002010129 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190387
FDA Product Code
| MUJ | System, Planning, Radiation Therapy Treatment |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-27 |
| Device Publish Date | 2019-09-19 |
On-Brand Devices [RayStation]
| 07350002010112 | 8.0 |
| 07350002010075 | 6.2 |
| 07350002010068 | 7 |
| 07350002010037 | 6.1 |
| 07350002010020 | 5.0.3 |
| 07350002010013 | 6.0 |
| 07350002010174 | 9 |
| 07350002010129 | 8.1 |
| 07350002010297 | 9B SP1 |
| 07350002010389 | 11.0 |
| 07350002010433 | 11.0.1 |
| 07350002010365 | 10.0.1 |
| 07350002010310 | 10.1 |
| 07350002010303 | 10.0 |
| 07350002010235 | 8.1.2 |
| 07350002010204 | 8.1.1 |
| 07350002010136 | 8.0.1 |
| 07350002010082 | 6.1.1 |
| 07350002010471 | 10B SP1 |
| 07350002010501 | 11B SP2 |
| 07350002010495 | 11B SP1 |
| 07350002010440 | 11A SP2 |
| 07350002010426 | 11B |
| 07350002010679 | 12A SP1 |
| 07350002010570 | 11B SPT1 |
| 07350002010549 | 12A |
| 07350002010556 | 2023B |
| 07350002010730 | 12A SP2 |
Trademark Results [RayStation]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RAYSTATION 79067539 3689690 Live/Registered |
RaySearch Laboratories AB 2009-03-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.