| Primary Device ID | B36556300MI450 |
| NIH Device Record Key | 333f722b-be0e-4f18-af44-787e68ab44fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wedge Filter, In- Plane, MLC, 45 Degrees, Siemens |
| Version Model Number | 56-300-MI45 |
| Company DUNS | 787178920 |
| Company Name | Aktina Corp. |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B36556300MI450 [Primary] |
| IYE | Accelerator, Linear, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| B3658080000 - isoPoint Validation Software | 2024-07-09 Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz t |
| B36550366050 - Circular Small Field Cone Insert, Varian, 5mm | 2021-06-01 |
| B36550366060 - Circular Small Field Cone Insert, Varian, 6mm | 2021-06-01 |
| B36550366070 - Circular Small Field Cone Insert, Varian, 7mm | 2021-06-01 |
| B36550366080 - Circular Small Field Cone Insert, Varian, 8mm | 2021-06-01 |
| B36550366090 - Circular Small Field Cone Insert, Varian, 9mm | 2021-06-01 |
| B36550366100 - Circular Small Field Cone Insert, Varian, 10mm | 2021-06-01 |
| B36550366110 - Circular Small Field Cone Insert, Varian, 11mm | 2021-06-01 |