Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004705634

FEI Number

3004705634

Entity Name

SONOSCAPE MEDICAL CORP.

City/State/Country

SHENZHEN Guangdong, CN

Establishment Address

Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District,, SHENZHEN Guangdong 518057, 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

Expiration Date (Year)

2026

510(k) Number

K222596

PMA Number

N/A

All Registered Proprietary Names

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 P10 Series 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 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 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 X5 Series Digital Color Doppler Ultrasound System P20 Series X3 Series Digital Colro Doppler Ultrasound System S9 Exp Portable Digital Color Doppler Ultrasound System S9 Portable Digital Color Doppler Ultrasound System S60 Elite&S70 Series Digital Color Doppler Ultrasound 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 P50 Series Digital Color Doppler Ultrasound System S2 Portable 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 S30/S40 Digital Color Doppler Ultrasound System S60 Series Digital Color Doppler Ultrasound System Biopsy Bracket S50 Digital Color Doppler Ultrasound System S12 Digital Color Doppler Ultrasound System 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 S11 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

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	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
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
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
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
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	2019-01-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-01-30
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-01-30
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	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
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
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
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	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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-05-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-05-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-05-06
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
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	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
OIJ	Biopsy Needle Guide Kit	Radiology	Class 2	892.1560	2025-09-29
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
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	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
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	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

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
3015525240	SONOSCAPE MEDICAL CORP.	Shenzhen Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022	FujiFilm Healthcare Americas Corporation	2	Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024	FUJIFILM Healthcare Americas Corporation	2	Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004705634. Last updated year: 2026. Please use registration number 3004705634 when referencing this establishment in official correspondence.