FORESEE (4C) IMAGING SYSTEM

System, Imaging, Optical Coherence Tomography (oct)

DIAGNOSTIC PHOTONICS, INC

The following data is part of a premarket notification filed by Diagnostic Photonics, Inc with the FDA for Foresee (4c) Imaging System.

Pre-market Notification Details

Device IDK133209
510k NumberK133209
Device Name:FORESEE (4C) IMAGING SYSTEM
ClassificationSystem, Imaging, Optical Coherence Tomography (oct)
Applicant DIAGNOSTIC PHOTONICS, INC 1835 MARKET STREET 29TH FLOOR Philadelphia,  PA  19103
ContactJanice Hogan
CorrespondentJanice Hogan
DIAGNOSTIC PHOTONICS, INC 1835 MARKET STREET 29TH FLOOR Philadelphia,  PA  19103
Product CodeNQQ  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-17
Decision Date2014-03-17
Summary:summary

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