| 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 |
| 07340201502334 - Leksell Stereotactic System | 2025-02-20 DISPOSABLE INSERTS 4 PCS |
| 07340201501528 - Leksell Vantage Stereotactic System | 2024-12-09 Leksell Vantage Key |
| 07340201501504 - Leksell Vantage Stereotactic System | 2024-12-09 Leksell Vantage™ Support Arc |
| 07340201502129 - Leksell Vantage Stereotactic System | 2024-12-09 LEKSELL VANTAGE CARRIER |
| 07340201501511 - Leksell Vantage Stereotactic System | 2024-09-09 LEKSELL VANTAGE ARC SYSTEM |
| 07340201501887 - Leksell Vantage Stereotactic System | 2024-08-22 LEKSELL VANTAGE ARC SYSTEM |
| 07340201501337 - Leksell Vantage Stereotactic System | 2024-08-14 FirmFix™ 5 |
| 07340201501290 - Leksell Vantage Stereotactic System | 2024-08-13 FirmFix™ 3 |