SONOSCAPE MEDICAL CORP.

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3015525240

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015525240
FEI Number
3015525240
Entity Name
SONOSCAPE MEDICAL CORP.
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
SonoScape Medical Building, No.2 Road (West), Shuangming Blvd (South), Guangming High-tech Park(East), Guangming District, Shenzhen Guangdong 518107, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SONOSCAPE MEDICAL CORP. (Owner Number: 9063868)
Owner / Operator Contact Address
Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District,, Shenzhen, CN-GD 518057, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K152854
PMA Number
N/A

All Registered Proprietary Names

S12 Digital Color Doppler Ultrasound System Autra 70 Elite Digital Color Doppler Ultrasound System Autra CV Digital Color Doppler Ultrasound System Autra 65 Digital Color Doppler Ultrasound System Autra T Digital Color Doppler Ultrasound System Autra 90 Digital Color Doppler Ultrasound System Autra 90 Elite Digital Color Doppler Ultrasound System Autra 65i Digital Color Doppler Ultrasound System Autra 80W Digital Color Doppler Ultrasound System Autra RS Digital Color Doppler Ultrasound System Autra 55i Digital Color Doppler Ultrasound System Autra 90 CV Digital Color Doppler Ultrasound System Autra 75 Pro Digital Color Doppler Ultrasound System Autra 80 Elite Digital Color Doppler Ultrasound System Autra 85 Elite Digital Color Doppler Ultrasound System Autra 85 Digital Color Doppler Ultrasound System Autra 75W Digital Color Doppler Ultrasound System Autra 85 CV Digital Color Doppler Ultrasound System e-Autra Digital Color Doppler Ultrasound System Autra 55 Elite Digital Color Doppler Ultrasound System Autra 75 Digital Color Doppler Ultrasound System Autra 80 Digital Color Doppler Ultrasound System Autra Senior Digital Color Doppler Ultrasound System Autra 75 Elite Digital Color Doppler Ultrasound System Autra 80 CV Digital Color Doppler Ultrasound System Autra 65 Elite Digital Color Doppler Ultrasound System Autra 85W Digital Color Doppler Ultrasound System Autra 55 Digital Color Doppler Ultrasound System Autra 70 Digital Color Doppler Ultrasound System S60 Elite&S70 Series Digital Color Doppler Ultrasound Biopsy Bracket E11 Plus Digital Color Doppler Ultrasound System X10 Pro Digital Color Doppler Ultrasound System XR1 Digital Color Doppler Ultrasound System ER1 Digital Color Doppler Ultrasound System E11s Digital Color Doppler Ultrasound System SU11C PRO Digital Color Doppler Ultrasound System SU11B PRO Digital Color Doppler Ultrasound System X11 Super Digital Color Doppler Ultrasound System E10T Digital Color Doppler Ultrasound System X10s Digital Color Doppler Ultrasound System X11 Plus Digital Color Doppler Ultrasound System SU11A EXP Digital Color Doppler Ultrasound System SU11A CU Digital Color Doppler Ultrasound System SU11B EXP Digital Color Doppler Ultrasound System SU11B CU Digital Color Doppler Ultrasound System E10 Plus Digital Color Doppler Ultrasound System X11 Digital Color Doppler Ultrasound System X10 Digital Color Doppler Ultrasound System X10T Digital Color Doppler Ultrasound System SU11B AD Digital Color Doppler Ultrasound System X10 Senior Digital Color Doppler Ultrasound System XR3 Digital Color Doppler Ultrasound System E11 Pro Digital Color Doppler Ultrasound System E11 Digital Color Doppler Ultrasound System X10 Elite Digital Color Doppler Ultrasound System X11U Digital Color Doppler Ultrasound System X10i Digital Color Doppler Ultrasound System X11i Digital Color Doppler Ultrasound System SU11A AD Digital Color Doppler Ultrasound System XR2 Digital Color Doppler Ultrasound System X11R Digital Color Doppler Ultrasound System X11s Digital Color Doppler Ultrasound System X11 Pro Digital Color Doppler Ultrasound System X11T Digital Color Doppler Ultrasound System E11i Digital Color Doppler Ultrasound System X10 Super Digital Color Doppler Ultrasound System E10 Digital Color Doppler Ultrasound System X10 Exp Digital Color Doppler Ultrasound System E10 Pro Digital Color Doppler Ultrasound System ER3 Digital Color Doppler Ultrasound System SU11C EXP Digital Color Doppler Ultrasound System ER2 Digital Color Doppler Ultrasound System SU11C AD Digital Color Doppler Ultrasound System E10i Digital Color Doppler Ultrasound System X10 Plus Digital Color Doppler Ultrasound System X11 Senior Digital Color Doppler Ultrasound System X11 Elite Digital Color Doppler Ultrasound System X11 Exp Digital Color Doppler Ultrasound System E11T Digital Color Doppler Ultrasound System E10s Digital Color Doppler Ultrasound System SU11A PRO Digital Color Doppler Ultrasound System X10R Digital Color Doppler Ultrasound System E11 Elite Digital Color Doppler Ultrasound System X10U Digital Color Doppler Ultrasound System SU11C CU Digital Color Doppler Ultrasound System S9 Exp Portable Digital Color Doppler Ultrasound System S9 Portable Digital Color Doppler Ultrasound System P50 Series Digital Color Doppler Ultrasound System P60 Exp Digital Color Doppler Ultrasound System P55 Digital Color Doppler Ultrasound System P55 Elite Digital Color Doppler Ultrasound System P40T Digital Color Doppler Ultrasound System P60S Digital Color Doppler Ultrasound System P50 Elite Digital Color Doppler Ultrasound System P25S Digital Color Doppler Ultrasound System P60 VO Digital Color Doppler Ultrasound System P40E Digital Color Doppler Ultrasound System P60 Pro Digital Color Doppler Ultrasound System P30T Digital Color Doppler Ultrasound System P50E Digital Color Doppler Ultrasound System P70S Digital Color Doppler Ultrasound System P60 CV Digital Color Doppler Ultrasound System P22S Digital Color Doppler Ultrasound System P30 Elite Digital Color Doppler Ultrasound System P70T Digital Color Doppler Ultrasound System P30E Digital Color Doppler Ultrasound System P40 Elite Digital Color Doppler Ultrasound System P50T Digital Color Doppler Ultrasound System P55S Digital Color Doppler Ultrasound System P60 Digital Color Doppler Ultrasound System SonoStage M1 Digital Color Doppler Ultrasound System X3 Series Digital Colro Doppler Ultrasound System P12N Digital Color Doppler Ultrasound System P11 Pro Digital Color Doppler Ultrasound System R11 Digital Color Doppler Ultrasound System P11 Elite Digital Color Doppler Ultrasound System P9 Elite Digital Color Doppler Ultrasound System P10N Digital Color Doppler Ultrasound System P12 Pro Digital Color Doppler Ultrasound System R10 Digital Color Doppler Ultrasound System P12 Exp Digital Color Doppler Ultrasound System R9 Digital Color Doppler Ultrasound System P11N Digital Color Doppler Ultrasound System P12 Elite Digital Color Doppler Ultrasound System P11 Exp Digital Color Doppler Ultrasound System M11 Digital Color Doppler Ultrasound System R12/P12N/P11 Exp/P11 Elite/P11 Pro/ R11/P11N/P10 Elite/P10N/R10/P9 Elite/M11/R9 P10 Elite Digital Color Doppler Ultrasound System S11 Digital Color Doppler Ultrasound System P20 Series S45 Digital Color Doppler Ultrasound System S60 Series Digital Color Doppler Ultrasound System S22 Digital Color Doppler Ultrasound System P40E Digital Color Doppler Ultrasound System P30T Digital Color Doppler Ultrasound System P60 Exp Digital Color Doppler Ultrasound System P60S Digital Color Doppler Ultrasound System P50E Digital Color Doppler Ultrasound System P25S Digital Color Doppler Ultrasound System P55 Digital Color Doppler Ultrasound System P30E Digital Color Doppler Ultrasound System P40T Digital Color Doppler Ultrasound System P22S Digital Color Doppler Ultrasound System P50 Elite Digital Color Doppler Ultrasound System P40 Elite Digital Color Doppler Ultrasound System P50T Digital Color Doppler Ultrasound System P55S Digital Color Doppler Ultrasound System P30 Elite Digital Color Doppler Ultrasound System P70T Digital Color Doppler Ultrasound System P55 Elite Digital Color Doppler Ultrasound System P60 VO Digital Color Doppler Ultrasound System P60 CV Digital Color Doppler Ultrasound System P60 Pro Digital Color Doppler Ultrasound System P70S Digital Color Doppler Ultrasound System P60 Digital Color Doppler Ultrasound System EC-550L Video Colonoscope VLS-55Q Light Source VLS-51D Light Source EG-550L Video Gastroscope VLS-51T Light Source EC-550T Video Colonoscope HD-550 Image Processor HD-550S Image Processor EC-550 Video Colonoscope EC-550L/T Video Colonoscope VLS-55T Light Source HD-500Plus Image Processor EG-550 Video Gastroscope S30/S40 Digital Color Doppler Ultrasound System I80-Surg Digital Color Doppler Ultrasound System I70-Endo Digital Color Doppler Ultrasound System S80 Exp Digital Color Doppler Ultrasound System P80T Digital Color Doppler Ultrasound System P70i Digital Color Doppler Ultrasound System P80 Pro Digital Color Doppler Ultrasound System S80 Digital Color Doppler Ultrasound System P90i Digital Color Doppler Ultrasound System S90 Exp Digital Color Doppler Ultrasound System S80 Senior Digital Color Doppler Ultrasound System P80 Elite Digital Color Doppler Ultrasound System P80 Senior Digital Color Doppler Ultrasound System P80 Exp Digital Color Doppler Ultrasound System S80 Elite Digital Color Doppler Ultrasound System P80 Plus Digital Color Doppler Ultrasound System I75-Endo Digital Color Doppler Ultrasound System S80T Digital Color Doppler Ultrasound System S80 Pro Digital Color Doppler Ultrasound System S70i Digital Color Doppler Ultrasound System S80 Plus Digital Color Doppler Ultrasound System P80 Super Digital Color Doppler Ultrasound System P80 Digital Color Doppler Ultrasound System S80 Super Digital Color Doppler Ultrasound System S100 Exp Digital Color Doppler Ultrasound System I80-Endo Digital Color Doppler Ultrasound System P20 Elite Digital Color Doppler Ultrasound System P20 Exp Digital Color Doppler Ultrasound System P15 Exp Digital Color Doppler Ultrasound System P25 Exp Digital Color Doppler Ultrasound System P22 Elite Digital Color Doppler Ultrasound System P25 Elite Digital Color Doppler Ultrasound System P15 Elite Digital Color Doppler Ultrasound System P22 Exp Digital Color Doppler Ultrasound System P10 Series S50 Digital Color Doppler Ultrasound System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-11-25
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-11-25
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-11-25
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-05-25
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-05-25
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-05-25
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-08-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-08-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-08-05
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2025-09-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-12-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-12-08
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-12-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-11-25
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-11-25
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-11-25
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-07-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-07-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-07-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-02-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-02-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-02-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-07-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-07-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-07-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-09-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-09-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-09-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2013-07-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-07-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2013-07-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-03-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-03-16
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-03-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-04-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-04-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-04-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-10-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-10-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-10-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-02-28
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-02-28
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-02-28
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-07-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-07-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-07-24
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2022-09-19
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-09-19
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-09-19
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-04-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-04-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-02-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-02-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-02-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-09-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-09-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-09-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-03-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-03-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-03-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2016-02-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2016-02-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-02-03

Official Correspondent

Toki Wu

US Agent Details

Xuegong Shi Business: Bioprober Corporation Email: Xuegong.shi@bioprober.com Phone: (425) 9744253

Related Public Records

Same Entity

SONOSCAPE MEDICAL CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004705634 SONOSCAPE MEDICAL CORP. SHENZHEN Guangdong, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07
K142628 Siemens Medi Cal Solutions, Inc. Acuson SC2000 Diagnostic Ultrasound System 2014-10-10
K132171 Supersonic Imagine AIXPLORER 2013-09-24
K222441 Bk Medical Aps Ultrasound System 2300 2022-12-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015525240. Last updated year: 2026. Please use registration number 3015525240 when referencing this establishment in official correspondence.
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