FDA.reportPublic FDA data

SONOSCAPE MEDICAL CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30047056343004705634SONOSCAPE MEDICAL CORP.1N2026-01-01Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, Nanshan District, SHENZHEN Guangdong CN 518057
30103914453010391445SONOSCAPE MEDICAL CORP.1N2020-04-251/F(S), 4/F(B) & 5/F, Nanfeng Bldg, Nanshan Yungu Innovation Industrial Park, 4093 Liuxian Blvd., Taoyuan Sub Nanshan, SHENZHEN Guangdong CN 518055

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
229591855113749K254028Digital 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)IYN2026-05-15
229591358987878K252498Digital 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)IYN2025-12-05
229591237479805K241949Digital Color Doppler Ultrasound System (P60 Series)IYN2025-01-17
229591335889900K222596S90 Exp Series Digital Color Doppler Ultrasound SystemIYN2023-02-10
229591390221792K222020HD-550 Video Endoscope SystemNWB2022-09-08
229591156948245K221140P20 Elite Series Digital Color Doppler Ultrasound SystemIYN2022-09-13
229591435522533K221089P12 Elite Series Digital Color Doppler Ultrasound SystemIYN2022-09-15
229591976693930K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemIYN2020-07-30
1565271778060491K182648X5 Series Digital Color Doppler Ultrasound SystemIYN2019-01-29
229591778060491K182648X5 Series Digital Color Doppler Ultrasound SystemIYN2019-01-29
1565271654028606K173058P10 Series Digital Color Doppler Ultrasound SystemIYN2017-12-01
229591654028606K173058P10 Series Digital Color Doppler Ultrasound SystemIYN2017-12-01
1565271142218152K172993P20 Series Digital Color Doppler Ultrasound SystemIYN2017-12-05
229591142218152K172993P20 Series Digital Color Doppler Ultrasound SystemIYN2017-12-05
229591519258054K172082S60 Series Digital Color Doppler Ultrasound SystemIYN2017-09-21
1565271519258054K172082S60 Series Digital Color Doppler Ultrasound SystemIYN2017-09-21
229591819475985K171000P60 Series Digital Color Doppler Ultrasound SystemIYN2017-07-11
1565271819475985K171000P60 Series Digital Color Doppler Ultrasound SystemIYN2017-07-11
229592058453994K170999P50 Series Digital Color Doppler Ultrasound SystemIYN2017-07-12
1565272058453994K170999P50 Series Digital Color Doppler Ultrasound SystemIYN2017-07-12
229591020186558K170303E5 Series Digital Color Doppler Ultrasound SystemIYN2017-05-19
1565271020186558K170303E5 Series Digital Color Doppler Ultrasound SystemIYN2017-05-19
1565271997356690K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemIYN2017-01-03
229591997356690K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemIYN2017-01-03
229591111475901K160283S45 Digital Color Doppler Ultrasound SystemIYN2016-04-04
1565271111475901K160283S45 Digital Color Doppler Ultrasound SystemIYN2016-04-04
229591317176176K160258X5 Digital Color Doppler Ultrasound SystemIYN2016-04-01
1565271317176176K160258X5 Digital Color Doppler Ultrasound SystemIYN2016-04-01
229591108289682K152854S50 Digital Color Doppler Ultrasound SystemIYN2016-01-13
1565271108289682K152854S50 Digital Color Doppler Ultrasound SystemIYN2016-01-13
1565271654525528K152396S12 Digital Color Doppler Ultrasound SystemIYN2015-09-03
229591654525528K152396S12 Digital Color Doppler Ultrasound SystemIYN2015-09-03
229591360396171K152165S9 Portable Digital Color Doppler Ultrasound SystemIYN2015-08-26
1565271360396171K152165S9 Portable Digital Color Doppler Ultrasound SystemIYN2015-08-26
229591082884751K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemIYN2015-08-28
1565271082884751K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemIYN2015-08-28
1565271886590844K150045S30/S40 Digital Color Doppler Ultraound SystemIYN2015-04-28
229591886590844K150045S30/S40 Digital Color Doppler Ultraound SystemIYN2015-04-28
1565271186440178K142815S22 Digital Color Doppler Ultrasound SystemIYN2015-01-28
229591186440178K142815S22 Digital Color Doppler Ultrasound SystemIYN2015-01-28
1565271155840187K132527DIGITAL COLOR DOPPLER ULTASOUND SYSTEMIYN2013-11-14
229591155840187K132527DIGITAL COLOR DOPPLER ULTASOUND SYSTEMIYN2013-11-14
1565271212284206K130801DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYN2013-06-14
229591212284206K130801DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYN2013-06-14
1565271005786173K130119PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYN2013-04-12
229591005786173K130119PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYN2013-04-12
1565271371994570K123616PORTABLE ULTRASONIC DIAGNOSTIC SYSTEMIYO2012-12-21
229591371994570K123616PORTABLE ULTRASONIC DIAGNOSTIC SYSTEMIYO2012-12-21
1565271036702997K112602S6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-11-07
229591036702997K112602S6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-11-07
229591127726322K112451S8 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-09-16
1565271127726322K112451S8 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-09-16
1565271678060786K110510S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYN2011-05-16
229591678060786K110510S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYN2011-05-16
229591767433295K102642SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICROIYN2011-03-04
1565271767433295K102642SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICROIYN2011-03-04
229591691626430

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN542026-05-15
IYO22012-12-21
NWB12022-09-08

PMN#

GUDID#

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