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 |