FDA.reportPublic FDA data

Ultrasonic A/B Scanner for Ophthalmology

Primary DI
06948941102213
Brand
Ultrasonic A/B Scanner for Ophthalmology
Company
Meda Co., Ltd
Model
ODM-2100
Device description
ODM-2100 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948941102213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948941102213069489411022136948941102213

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545188828
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948941132005Ultrasound BiomicroscopeMD-320W2021-12-18
06948941160015Bladder ScannerMD-6000P2019-07-01
06948941111116Ultrasonic PachymeterMD-1000P2016-09-01
06948941111123Ultrasonic Biometer for OphthalmologyMD-1000A/P2016-09-01
06948941102220Ultrasonic A/B Scanner for OphthalmologyODM-22002016-09-01
06948941102237Ultrasonic A/B Scanner for OphthalmologyMD-2300S 2016-09-01
06948941111109Ultrasonic Biometer for OphthalmologyMD-1000A2016-09-01
06948941160008Bladder ScannerMD-60002016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
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08056304455437MyLabA50ESAOTE SPAITX2025-07-07
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08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
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