The following data is part of a premarket notification filed by Spectral Md, Inc with the FDA for Deepview Digital Video Physiological Portable Imaging System.
| Device ID | K124049 |
| 510k Number | K124049 |
| Device Name: | DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | Spectral MD, Inc 1201 RICHARDSON DRIVE, SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford Spectral MD, Inc 1201 RICHARDSON DRIVE, SUITE 280 Richardson, TX 75080 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-31 |
| Decision Date | 2013-04-18 |
| Summary: | summary |