| Primary Device ID | 07340201502136 |
| NIH Device Record Key | 61d2e8e0-c2b5-4549-a09d-296e80fecf04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leksell GammaPlan |
| Version Model Number | 1567714 |
| Company DUNS | 353272181 |
| Company Name | Elekta Solutions AB |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07340201502136 [Primary] |
| IWB | System, Radiation Therapy, Radionuclide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-22 |
| Device Publish Date | 2024-02-14 |
| 07340201503782 - AQUA | 2025-12-18 AQUA V3.3 Machine QA Software |
| 07340201502273 - Leksell Stereotactic System | 2025-09-25 Post Insulated anterior |
| 07340201503317 - Leksell Stereotactic System | 2025-09-25 Instrument Screwdriver, Double |
| 07340201502440 - Leksell Stereotactic System | 2025-09-25 Ear Plug Holders |
| 07340201502921 - Leksell Stereotactic System | 2025-09-25 Slotted Front Piece |
| 07340201502914 - Leksell Stereotactic System | 2025-09-25 Post Insulated posterior long |
| 07340201502488 - Leksell Stereotactic System | 2025-09-25 Curved Front Piece |
| 07340201503287 - Leksell Stereotactic System | 2025-09-25 Insulated Curved Post |