| Primary Device ID | 00851147007113 |
| NIH Device Record Key | 4be71d5c-600b-4726-bbba-e6fa64dabc9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Decimal3D |
| Version Model Number | N/A |
| Company DUNS | 617041967 |
| Company Name | DECIMAL, INC. |
| 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 | 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 | 00851147007113 [Primary] |
| MUJ | System, Planning, Radiation Therapy Treatment |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-09 |
| Device Publish Date | 2022-12-01 |
| 00851147007144 - .decimal Blocking Tray | 2023-07-27 Accessory |
| 00851147007113 - Decimal3D | 2022-12-093D Scanning and Digitizing Application for Electron Therapy Apertures |
| 00851147007113 - Decimal3D | 2022-12-09 3D Scanning and Digitizing Application for Electron Therapy Apertures |
| 00851147007137 - decimal Bolus (FlexiBol) | 2022-12-09 decimal Silicone Bolus |
| 00851147007120 - .decimal Astroid Planning App 3.x | 2022-12-01 The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments. |
| 00851147007007 - .decimal Proton Aperture | 2018-07-06 .decimal Proton Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is custom and unique |
| 00851147007014 - .decimal Proton Range Compensator | 2018-07-06 Custom manufactured solid Range Compensators for intensity modulation of external beam proton radiation therapy. |
| 00851147007021 - .decimal Electron Bolus | 2018-07-06 A custom manufactured solid Bolus Compensators for intensity modulation of external beam radiation therapy. |
| 00851147007038 - .decimal Electron Aperture | 2018-07-06 A custom made device that shapes and focuses the electron beam aimed at the cancerous tissue. |