CANON INC.

GUDID 04549292182729

CANON INC.

Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera
Primary Device ID04549292182729
NIH Device Record Keydadccc34-c13d-4ecb-a40d-b447d8a87623
Commercial Distribution StatusIn Commercial Distribution
Brand NameCANON INC.
Version Model NumberimageSPECTRUM
Company DUNS695138065
Company NameCANON INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104549292182729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFJSystem, Image Management, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-26
Device Publish Date2020-10-16

On-Brand Devices [CANON INC.]

04960999999708CXDI-801C Wireless
04960999999043CXDI-401C Wireless
04960999989600CXDI-701C Wireless
04960999988184CXDI-55C
04960999974965CXDI-70C Wireless
04960999814735CXDI-501C
04960999814728CXDI-501G
04960999812601CXDI-401G COMPACT
04960999810911CXDI-50RF
04549292099478CXDI-410C Wireless
04549292099454CXDI-810C Wireless
04549292099447CXDI-710C Wireless
04549292075182CSX-20
04549292075175CSX-30
04549292074369TX-20
04549292074352RK-F2
04549292074345CX-1
04549292074338CR-2 Plus AF
04549292074321CR-2 AF
04549292049695CXDI-401C COMPACT
04549292084696Ophthalmic Software Platform RX
04549292168679CXDI-402C Wireless
04549292167436CXDI-702C Wireless
04549292182729imageSPECTRUM
04549292200935CXDI-Pro
04549292200942CXDI-Elite

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