FDA.reportPublic FDA data

Delica

Primary DI
06970481940024
Brand
Delica
Company
Shenzhen Delica Medical Equipment Co., Ltd.
Model
EMS-9U2
Device description
Transcranial Doppler Ultrasound System
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060112000NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEMNodecrest, LLC2006-05-05IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970481940024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970481940024069704819400246970481940024

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, line-poweredA mains electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis), ankle pressure index, and/or blood flow wave form recording.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544412009
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970481940093DelicaEMS-9D PRO2019-06-20
06970481940109DelicaEMS-9D EXP2019-06-20
06970481940031DelicaEMS-9UA2016-09-19
06970481940048DelicaEMS-9PB2016-09-19
06970481940017DelicaEMS-9U12023-06-21
06970481940161DelicaEMS-9M22022-07-25
06970481940178DelicaEMS-9M12022-07-25
06970481940079DelicaEMS-9D2018-07-17
06970481940086DelicaEMS-9F2018-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841517112684C5-1FUJIFILM SONOSITE, INC.IYN2026-08-07
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27