Definition: The System Reports Two Sets Of Numbers Under Two Different Conditions, One With Capacitive Barrier To Minimize The Effect Of Variables Such As Oils And Sweat On The Image And One Without The Capacitive Barrier. The Response Scale Reports Numerical Me
| Device Type ID | 3789 |
| Device Name | Evoked Photon Image Capture Device |
| Physical State | The System Includes The Following Components: (1) The Device, (2) Power Cord, (3) USB External Cable, (4) Electrode Cover, (5) Finger Shroud, (6) Reference Probe, (7) Reference Probe Cable, (8) Reference Probe Shroud, (9) Instructions For Use, (10) C |
| Technical Method | The System Consists Of The Hardware Attached To A Computer/software System. The Measurements Are Digital Photographs Acquired When Placing A Fingertip In Contact With A Glass Electrode. A Series Of Electrical Impulses Are Applied To The Glass Electro |
| Target Area | Finger Tips |
| Regulation Description | Evoked Photon Image Capture Device. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 882.1561 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PNA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3789 |
| Device | Evoked Photon Image Capture Device |
| Product Code | PNA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Evoked Photon Image Capture Device. |
| CFR Regulation Number | 882.1561 [🔎] |