| Primary Device ID | 16280558580020 |
| NIH Device Record Key | 851ab1f4-b6a9-4c00-bd99-cac7664ae0a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fusion Bx |
| Version Model Number | 2.0 |
| Company DUNS | 200507997 |
| Company Name | Focal Healthcare 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 | true |
| Manufacturing Date | true |
| 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 | 16280558580020 [Primary] |
| GS1 | 26280558580027 [Package] Package: [1 Units] In Commercial Distribution |
| 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 | 2018-10-01 |
| Device Publish Date | 2018-08-31 |
| 16280558580020 | Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultr |
| 26280558580010 | Fusion Bx is designed to display the 2D live video received from commercially available ultrasou |
| 00628055858010 | Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultr |
| 00628055858003 | Fusion Bx is designed to display the 2D live video received from commercially available ultrasou |