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Sonoscape Medical Corp.: FDA-registered device maker in SHENZHEN Guangdong, China, 25 510(k) clearances

Name: Sonoscape Medical Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sonoscape Medical Corp. is registered with the FDA (registration 3004705634) in SHENZHEN Guangdong, China. It lists 7 device types. The FDA files 25 510(k) clearances under its listings, the newest dated May 15, 2026. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch Sonoscape Medical Corp.

FDA registration number: 3004705634
Address: Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict Nanshan District, SHENZHEN Guangdong, China, 518057
Owner or operator: SONOSCAPE MEDICAL CORP. (9063868)
Roles: Manufacturer
First device listed: May 6, 2013
Registered through: 2026
Brand names listed: Autra 55 Digital Color Doppler Ultrasound System, Autra 55 Elite Digital Color Doppler Ultrasound System, Autra 55i Digital Color Doppler Ultrasound System, Autra 65 Digital Color Doppler Ultrasound System, Autra 65 Elite Digital Color Doppler Ultrasound System, Autra 65i Digital Color Doppler Ultrasound System, Autra 70 Digital Color Doppler Ultrasound System, Autra 70 Elite Digital Color Doppler Ultrasound System and more

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle Guide Kit	OIJ	2	Manufacturer	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Manufacturer	accessdata.fda.gov
Endoscope, Accessories, Narrow Band Spectrum	NWB	2	Manufacturer	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 15, 2026	K254028	Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
December 5, 2025	K252498	Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
January 17, 2025	K241949	Digital Color Doppler Ultrasound System (P60 Series)	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
February 10, 2023	K222596	S90 Exp Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
September 15, 2022	K221089	P12 Elite Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
September 13, 2022	K221140	P20 Elite Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
September 8, 2022	K222020	HD-550 Video Endoscope System	NWB	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
July 30, 2020	K201059	S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
January 29, 2019	K182648	X5 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
December 5, 2017	K172993	P20 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
December 1, 2017	K173058	P10 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
September 21, 2017	K172082	S60 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
July 12, 2017	K170999	P50 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
July 11, 2017	K171000	P60 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
May 19, 2017	K170303	E5 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
January 3, 2017	K163427	X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
April 4, 2016	K160283	S45 Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
January 13, 2016	K152854	S50 Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
September 3, 2015	K152396	S12 Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
August 28, 2015	K152164	S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
August 26, 2015	K152165	S9 Portable Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
April 28, 2015	K150045	S30/S40 Digital Color Doppler Ultraound System	IYN	Substantially Equivalent	Sonoscape Company Limited	accessdata.fda.gov
January 28, 2015	K142815	S22 Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Company Limited	accessdata.fda.gov
June 14, 2013	K130801	DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Sonoscape Company Limited	accessdata.fda.gov
April 12, 2013	K130119	PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Sonoscape Company Limited	accessdata.fda.gov

Compare with other makers

Updated May 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.