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510(k) K132800

SKINTELL by Agfa Healthcare N.V. — Product Code NQQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2014
Date Received
September 6, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Optical Coherence Tomography (Oct)
Device Class
Class II
Regulation Number
892.1560
Review Panel
SU
Submission Type

This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.

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