FDA.reportPublic FDA data

CANON INC.

Primary DI
04549292074369
Brand
CANON INC.
Company
CANON INC.
Model
TX-20
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKXTonometer, Ac-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111710000FULL AUTO TONOMETER MODEL TX-20Canon Inc. -Medical Equipment Group2011-09-20HKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04549292074369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04549292074369045492920743694549292074369

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, line-poweredAn ophthalmic, line-powered, measuring instrument used for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-970-7227xx@xx.xx

Regulatory Flags#

DUNS number
695138065
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719872711230MiiSMEDIMAGING INTEGRATED SOLUTION INC.HKX2026-04-29
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06430033851920iCare ST500ICARE FINLAND OYHKX2025-12-05
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONHKX2025-11-17
07350023774307CalcibonBiomet Biologics, LLCHKX2025-10-09
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKX2025-03-11
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
06430033851784ST500 SmartCradleICARE FINLAND OYHKX2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKX2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKX2024-11-07
06430033851883iCare ST500ICARE FINLAND OYHKX2024-11-07
00851158007683Eli EzerU.S. OPHTHALMIC, L.L.C.HKX2024-01-25
04547451026686INAMI INAMI & CO., LTD.HKX2023-07-27
04547451026709INAMIINAMI & CO., LTD.HKX2023-07-27
03615020000458WAVE ANALYZER MEDICA 800ESSILOR INTERNATIONALHKX2023-07-25
08800019600411Applanation Tonometer HT-5000Huvitz Co., Ltd.HKX2023-06-12
08800019600435Non-contact Tonometer HNT-1PHuvitz Co., Ltd.HKX2023-06-12
08800019600558Auto Tono/Refracto/Kerato/Pachymeter HTR-1AHuvitz Co., Ltd.HKX2023-06-12
03664188000145Visionix VX650LUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
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03664188000930RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
04047844051269DIPLOMAT Def.SIGNUS Medizintechnik GmbHHKX2022-06-20
04047844051276DIPLOMAT Def.SIGNUS Medizintechnik GmbHHKX2022-06-20
04582273600263NON-CONTACT TONOMETERTOMEY CORPORATION.HKX2022-04-01
00851158007706Eli EzerU.S. OPHTHALMIC, L.L.C.HKX2021-01-04
M6333974340JEDMEDJEDMED INSTRUMENT COMPANYHKX2020-09-01
03664188000039VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKX2020-05-25
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