FDA.reportPublic FDA data

7LT4s Ultrasonic Transducer(FDA)

Primary DI
06944904088877
Brand
7LT4s Ultrasonic Transducer(FDA)
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
PL1H-30-90894
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, ultrasonic, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102991000M5 DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010-10-22IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944904088877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904088877069449040888776944904088877

GMDN Terms#

Term, Definition table
TermDefinition
Surgical ultrasound imaging transducerA hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. This group of devices includes ultrasound imaging transducer assemblies used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+8675581888998service@mindray.com.cn

Regulatory Flags#

DUNS number
654671304
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06903053124348Diagnostic Ultrasound SystemMU9 Pro2026-06-03
06903053124355Diagnostic Ultrasound SystemMU9A2026-06-03
06903053124379Diagnostic Ultrasound SystemMU7 Pro2026-06-03
06903053124430Diagnostic Ultrasound SystemMU9 Super2026-06-03
06903053124461Diagnostic Ultrasound SystemMU72026-06-03
06903053124492Diagnostic Ultrasound SystemMU7 Super2026-06-03
06903053124546Diagnostic Ultrasound SystemMU9S2026-06-03
06903053124560Diagnostic Ultrasound SystemMU9P2026-06-03
06903053124591Diagnostic Ultrasound SystemMU92026-06-03
06903053124607Diagnostic Ultrasound SystemMU7S2026-06-03
06903053124614Diagnostic Ultrasound SystemMU7A2026-06-03
06903053124683Diagnostic Ultrasound SystemMU9T2026-06-03
06903053124706Diagnostic Ultrasound SystemMU7T2026-06-03
06903053124720Diagnostic Ultrasound SystemMU7P2026-06-03
06903053124775Diagnostic Ultrasound SystemMU9 Exp2026-06-03
06903053124829Diagnostic Ultrasound SystemMU7 Exp2026-06-03
06936415904661MR Na/K Check Solution105-011386-002026-01-23
06936415904678MR Detergent Solution105-011383-002026-01-23
06936415904685MR Buffer Solution105-011382-002026-01-23
06944904084459Chemistry AnalyzerCLC720i2026-01-23

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00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
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00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
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08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
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