FDA.reportPublic FDA data

4Sight

Primary DI
00897826002079
Brand
4Sight
Company
ACCUTOME, INC.
Model
24-8000
Catalog number
24-8000
Published
2016-09-13
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
00897826002079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00897826002079008978260020798978260020790897826002079

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound pachymeterA mains electricity (AC-powered), ophthalmic device designed to use ultrasound to measure the thickness of the cornea, and may in addition be designed to measure axial length and anterior chamber depth. A small ultrasound probe(s) that is connected to this device is placed directly onto the cornea to make the measurements which are recorded and displayed by the pachymeter. The data is used to evaluate refractive eye surgery [e.g., laser assisted in situ keratomileusis (LASIK) treatment], evaluate ocular measurements for calculating intraocular lens power, monitor epithelium regrowth, and for other ophthalmic measurement evaluations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
048792816
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00897826002086AccuTip CoverAX9950AX99502016-09-13
00897826002093AccuTip Cover AX11932AX119322016-09-13
00897826002109AccuTip Cover AX11526AX115262016-09-13
00897826002116AccuTip Cover AX11286AX112862016-09-13
00897826002000Accupen24-300024-30002016-09-13
00897826002017Pachpen24-510024-51002016-09-13
00897826002024A-scan Plus Connect24-440024-44002016-09-13
00897826002031B-scan Plus24-610024-61002016-09-13
00897826002055Accupach VI24-620024-62002016-09-13
00897826002062B-scan Pro24-640024-64002016-09-13
008978260021474Sight: Software Package2.06.02-U2016-09-21
00897826002178B-scan Plus: Software Package4.07.02-U2016-09-21
00897826002185A-scan Plus Connect: Software Package7.00.02-U2016-09-21
00897826002192B-scan Plus Software Package: Veterinary Version1.03.03-U2016-09-23
00897826002208B-scan Pro Software Package: Veterinary Version4.07.02-U2016-09-23
00897826002222B-scan Plus- VET24-6100-V24-6100-V2016-10-14
00897826002239B-scan Pro- VET24-6400-V24-6400-V2016-10-14
00897826002253Pachpen- VET24-5100-V24-5100-V2016-10-14
00897826002048UBM Plus24-630024-63002016-09-13
00897826002161UBM Plus: Software Package4.07.02-U2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
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08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455017MyLabA50ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07
08056304455628MyLabE80ESAOTE SPAIYO2024-03-29
08056304455628MyLabE80ESAOTE SPAITX2024-03-29
08056304454980MyLabX90ESAOTE SPAITX2023-12-14
08056304454980MyLabX90ESAOTE SPAIYO2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYO2023-12-14
08056304454676MyLabX9ESAOTE SPAITX2023-06-13
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONIYO2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONITX2021-11-29
08056304454386MyLabX75ESAOTE SPAIYO2021-09-24
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19