Caption Guidance 511-00021
GUDID 00860003586334
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
CAPTION HEALTH, INC.
Ultrasound imaging system application software| Primary Device ID | 00860003586334 |
| NIH Device Record Key | c53021c8-6c47-4620-956a-9bf4dbc23d55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Caption Guidance |
| Version Model Number | Apollo |
| Catalog Number | 511-00021 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003586334 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN190040
FDA Product Code
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence |
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 | 2023-10-09 |
| Device Publish Date | 2023-09-30 |
Devices Manufactured by CAPTION HEALTH, INC.
| 00860003586341 - Caption AI (Caption Guidance + Caption Interpretation) | 2024-04-09 |
| 00860003586334 - Caption Guidance | 2023-10-09The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). |
| 00860003586334 - Caption Guidance | 2023-10-09 The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Capti |
| 00860003586310 - Caption AI (Caption Guidance + Caption Interpretation) | 2022-03-23 Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound. The Caption Guidance software is indicat |
| 00860003586303 - Caption AI (Caption Guidance + Caption Interpretation) | 2022-01-25 The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, |
Trademark Results [Caption Guidance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPTION GUIDANCE 88574778 not registered Live/Pending |
Bay Labs, Inc. 2019-08-12 |
 CAPTION GUIDANCE 88574775 not registered Live/Pending |
Bay Labs, Inc. 2019-08-12 |
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