| Primary Device ID | 00860003586310 |
| NIH Device Record Key | 8256d83d-6575-4021-ae97-99ee7dfbfdd4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Caption AI (Caption Guidance + Caption Interpretation) |
| Version Model Number | 0.2.8 |
| Catalog Number | 511-00019 |
| Company DUNS | 079192179 |
| Company Name | CAPTION HEALTH, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 00860003586303 [Previous] |
| GS1 | 00860003586310 [Primary] |
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-23 |
| Device Publish Date | 2022-03-15 |
| 00860003586303 | The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiogr |
| 00860003586310 | Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound. The Capt |
| 00860003586341 | Alastor |