CANON INC.

GUDID 04549292147216

CANON INC.

Retinal optical coherence tomography system
Primary Device ID04549292147216
NIH Device Record Keyaaace8ec-2bdc-4604-97f5-44e26c100b7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCANON INC.
Version Model NumberOCT-A1
Company DUNS690549662
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 Batchfalse
Serial Numbertrue
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
GS104549292147216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLIOphthalmoscope, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-12
Device Publish Date2025-05-02

On-Brand Devices [CANON INC.]

04549292074321CR-2 AF
04549292075182CSX-20
04549292075175CSX-30
04549292074369TX-20
04549292074345CX-1
04549292074338CR-2 Plus AF
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
04549292049695CXDI-401C COMPACT
04549292084696Ophthalmic Software Platform RX
04549292168679CXDI-402C Wireless
04549292167436CXDI-702C Wireless
04549292074352RK-F2
04549292182729imageSPECTRUM
04549292200935CXDI-Pro
04549292200942CXDI-Elite
04549292228489CR-10
04960999999050CXDI-801G Wireless
04960999989587CXDI-701G Wireless
04960999986647CXDI-55G
04549292147216OCT-A1

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