FDA.reportPublic FDA data

Diagnostic Ultrasound System

Primary DI
06903053063852
Brand
Diagnostic Ultrasound System
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
Imagyn A20 Exp
Published
2026-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
K261585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261585000Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2026-10-16IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06903053063852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06903053063852069030530638526903053063852

Regulatory Flags#

DUNS number
654671304
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06944904003825CABLE,IBP ADAPTER, 12PIN/6PIN0010-20-427952016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06903053063937Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063951Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063968Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063975Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063982Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064019Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064026Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064033Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064040Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064057Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064064Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
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