Head Cradle
GUDID B365501860
Aktina Corp.
Stereotactic radiosurgical/radiotherapy arch head frame| Primary Device ID | B365501860 |
| NIH Device Record Key | bf75f5cf-95fa-49ad-ba7e-3a48556c7c2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Head Cradle |
| Version Model Number | 50-186 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B365501860 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103616
FDA Product Code
| IYE | Accelerator, Linear, Medical |
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 | 2021-05-31 |
| Device Publish Date | 2021-05-21 |
Devices Manufactured by Aktina Corp.
| 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 |
Trademark Results [Head Cradle]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEAD CRADLE 78943675 not registered Dead/Abandoned |
Donna Watson 2006-08-02 |
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