| Primary Device ID | 00850681007184 |
| NIH Device Record Key | e31f564e-9cf5-4cb0-9344-1768ba99fd18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovaBot Automated Headset |
| Version Model Number | NA-RBT1 |
| Catalog Number | NA-RBT1 |
| Company DUNS | 078766464 |
| Company Name | Novasignal 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 | false |
| Serial Number | true |
| 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 | 00850681007184 [Primary] |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-08 |
| Device Publish Date | 2020-08-31 |
| 00850681007351 - NovaKit™ 2 Exam Pack | 2022-08-29 |
| 00850681007399 - NovaGuide™ 2 Intelligent Ultrasound System | 2022-08-29 |
| 00850681007405 - NovaGuide™ 2 Traditional Ultrasound System | 2022-08-29 |
| 00850681007443 - NovaGuide™ Intelligent Ultrasound System | 2022-08-29 |
| 00850681007184 - NovaBot Automated Headset | 2020-09-08NovaBot Automated Headset accessory for the Lucid TCD. When connected to the Lucid TCD, the combined device is referred to as the NovaGuide. The NovaBot is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid TCD (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient's temporal acoustic windows. |
| 00850681007184 - NovaBot Automated Headset | 2020-09-08 NovaBot Automated Headset accessory for the Lucid TCD. When connected to the Lucid TCD, the combined device is referred to as th |
| 10850681007198 - NovaKit Exam Pack (NovaKit) | 2020-09-08 The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padd |
| 00850681007221 - Lucid Transcranial Doppler Ultrasound System (Lucid TCD) | 2020-09-08 The Lucid TCD is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and |
| 10850681007174 - Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack | 2020-08-03 A box of 10 procedural sets that include replacement foam for the Neural Analytics Temporal Monitoring Headframe. |