FDA.reportPublic FDA data

Anesus ME7 Diagnostic Ultrasound System

Primary DI
06936415926724
Brand
Anesus ME7 Diagnostic Ultrasound System
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
Anesus ME7
Published
2025-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212900000
K241432000
K251192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212900000MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2021-11-05IYN
K241432000MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2024-09-12IYN
K251192000Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2025-08-22IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936415926724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936415926724069364159267246936415926724

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654671304
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06903053063852Diagnostic Ultrasound SystemImagyn A20 Exp2026-10-31
06903053063869Diagnostic Ultrasound SystemNuewa A20Q2026-10-31
06903053063876Diagnostic Ultrasound SystemNuewa A Lumi2026-10-31
06903053063883Diagnostic Ultrasound SystemNuewa A18W2026-10-31
06903053063890Diagnostic Ultrasound SystemNuewa A20 Exp2026-10-31
06903053063906Diagnostic Ultrasound SystemNuewa A20 Plus2026-10-31
06903053063913Diagnostic Ultrasound SystemNuewa A20 Elite2026-10-31
06903053063937Diagnostic Ultrasound SystemNuewa AR2026-10-31
06903053063944Diagnostic Ultrasound SystemNuewa A202026-10-31
06903053063951Diagnostic Ultrasound SystemNuewa A MS2026-10-31
06903053063968Diagnostic Ultrasound SystemImagyn A20S2026-10-31
06903053063975Diagnostic Ultrasound SystemNuewa A20S2026-10-31
06903053063982Diagnostic Ultrasound SystemNuewa A20 Premium2026-10-31
06903053064002Diagnostic Ultrasound SystemNuewa A20W2026-10-31
06903053064019Diagnostic Ultrasound SystemNuewa A20 Pro2026-10-31
06903053064026Diagnostic Ultrasound SystemNuewa A MV2026-10-31
06903053064033Diagnostic Ultrasound SystemImagyn A202026-10-31
06903053064040Diagnostic Ultrasound SystemNuewa A20T2026-10-31
06903053064057Diagnostic Ultrasound SystemNuewa A Elite2026-10-31
06903053064064Diagnostic Ultrasound SystemImagyn A20T2026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2026-11-04
06903053063852Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063869Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063876Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063883Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063906Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063913Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
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06903053063951Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063968Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
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