| Primary Device ID | 07340201500057 |
| NIH Device Record Key | 90de0544-465a-4c82-972a-992b12a4f0eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProKnow DS |
| Version Model Number | 2.0 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 07340201500057 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-29 |
| Device Publish Date | 2024-03-21 |
| 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 |
| 07340201502501 - Leksell Stereotactic System | 2025-09-25 MR-Adapter for GE Quadrature Head Coil |