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510(k) K201273

Device
ImageSPECTRUM
Applicant
Canon Inc.
510(k) number
K201273
Product code
NFF  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-25
Date received
2020-05-12
Regulation
892.2010
Classification name
Device, Storage, Images, Ophthalmic
Medical specialty
Radiology
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Akira Hirai
Address
9-1, Imaikami-Cho Nakahara-Ku, Kawasaki JP 211-8501 211-8501

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NFF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021787VISUCAMCarl Zeiss Ophthalmic Systems, Inc.2002-06-21

Legacy Summary#

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FDA Review#

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