ImageSPECTRUM

Device, Storage, Images, Ophthalmic

Canon Inc.

The following data is part of a premarket notification filed by Canon Inc. with the FDA for Imagespectrum.

Pre-market Notification Details

Device IDK201273
510k NumberK201273
Device Name:ImageSPECTRUM
ClassificationDevice, Storage, Images, Ophthalmic
Applicant Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki,  JP 211-8501
ContactAkira Hirai
CorrespondentRyan Bouchard
Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki,  JP 211-8501
Product CodeNFF  
Subsequent Product CodeHKI
Subsequent Product CodeNFG
Subsequent Product CodeNFJ
CFR Regulation Number892.2010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-12
Decision Date2020-09-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04549292182729 K201273 000
04549292182729 K201273 000
04549292182729 K201273 000
04549292182729 K201273 000
04549292182729 K201273 000
04549292182729 K201273 000
04549292182729 K201273 000
04549292182729 K201273 000
04549292182729 K201273 000

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