FDA 510(k), K133209, FORESEE (4C) IMAGING SYSTEM
FDA 510(k), K133209, FORESEE (4C) IMAGING SYSTEM
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510(K) Number: K133209
Device Name: FORESEE (4C) IMAGING SYSTEM
Manufacturer: DIAGNOSTIC PHOTONICS, INC
Device Classification Name: System, Imaging, Optical Coherence Tomography (Oct)
Regulation Number: 892.1560
Classification Product Code: NQQ
Date Received: 10/17/2013
Decision Date: 03/17/2014
Regulation Medical Specialty: Radiology
511 pages (1,316 of 1,827 original pages are fully redacted)