FDA.reportPublic FDA data

CANON INC.

Primary DI
04549292147216
Brand
CANON INC.
Company
CANON INC.
Model
OCT-A1
Published
2025-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HLIOphthalmoscope, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLIOphthalmoscope, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182942000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182942000Canon OCT-A1Canon, Inc.2019-07-24OBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04549292147216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04549292147216045492921472164549292147216

GMDN Terms#

Term, Definition table
TermDefinition
Retinal optical coherence tomography systemAn assembly of devices that uses a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement of the retina, the retinal nerve fibre layer (its thickness), and optic disk in order to diagnose and manage retinal diseases. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional images of the retina or three-dimensional (3-D) volume scans. Optical coherence tomography (OCT) is used for visualizing the area/location of retinal-thickness abnormalities, macular holes or oedema, atrophy associated with degenerative diseases, glaucoma, and other retinal pathologies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690549662
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987670100222INTERVENTIONAL ANGIOGRAPHY SYSTEMINFX-8000V2016-09-01
049876701013594ch Flex SPEEDERMJAJ-197A2016-09-01
04987670102493Vitrea Software Toshiba PackageVSTP-001A2018-03-02
04987670103360Vantage OrianMRT-15502018-11-30
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCUS-AME002026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCUS-ABE002026-06-01
04987670105579Aquilion ONETSX-308A2025-01-09
04987670103797CT SCANNERTSX-306A2021-11-01
04987670100741DIAGNOSTIC ULTRASOUND SYSTEMTUS-X100S2016-09-01
04987670100734DIAGNOSTIC ULTRASOUND SYSTEMTUS-X1002016-09-01
04987670100758DIAGNOSTIC ULTRASOUND SYSTEMTUS-X2002016-09-01
04987670100765DIAGNOSTIC ULTRASOUND SYSTEMTUS-X200S2016-09-01
04987670106095Aquilion Serve SPTSX-307B2024-07-04
04987670102721PHASED ARRAY TRANSDUCERPSU-60ST2026-03-01
04987670102745LINEAR ARRAY TRANSDUCERPLU-1003ST2026-03-01
04987670102752LINEAR ARRAY TRANSDUCERPLU-805ST2026-03-01
04987670102769PHASED ARRAY TRANSDUCERPSU-30ST2026-03-01
04987670102783LINEAR ARRAY TRANSDUCERPLU-704ST2026-03-01
04987670102806CW DOPPLER PENCIL TRANSDUCERPC-20ST2026-03-01
04987670102813DIAGNOSTIC ULTRASOUND SYSTEMTUS-VC1002026-03-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00697077003043Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2024-07-11
00697077003029Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2024-05-02
00732094086515Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094089202Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00697077002237Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2023-07-27
04053755119660INDIRECT OPHTHALMOSCOPE BINOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755120307INDIRECT OPHTHALMOSCOPE MONOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755153541OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755153695OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181704OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181711OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
00732094346930Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
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00732094346978Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094346985Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094346992Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347005Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347012Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347029Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
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