The following data is part of a premarket notification filed by Diagnostic Photonics, Inc with the FDA for Foresee (4c) Imaging System.
| Device ID | K133209 |
| 510k Number | K133209 |
| Device Name: | FORESEE (4C) IMAGING SYSTEM |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | DIAGNOSTIC PHOTONICS, INC 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice Hogan |
| Correspondent | Janice Hogan DIAGNOSTIC PHOTONICS, INC 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-03-17 |
| Summary: | summary |