510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sonoscape Medical Corp.

SHENZHEN Guangdong, CN

SONOSCAPE MEDICAL CORP. appears in FDA device records in SHENZHEN Guangdong, CN. FDA records list 25 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
25
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 25 510(k) clearances for Sonoscape Medical Corp. between 2015 and 2026. The busiest year on record is 2017, with 7. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sonoscape Medical Corp., by decision year
YearClearances
20153
20163
20177
20181
20191
20201
20224
20231
20241
20252
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254028Digital 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)IYNSubstantially Equivalent
K252498Digital 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)IYNSubstantially Equivalent
K241949Digital Color Doppler Ultrasound System (P60 Series)IYNSubstantially Equivalent
K231813Ultrasonic GastrovideoscopeODGSubstantially Equivalent
K222596S90 Exp Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K221089P12 Elite Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K221140P20 Elite Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K222020HD-550 Video Endoscope SystemNWBSubstantially Equivalent
K211882HD-550 Video Endoscope SystemNWBSubstantially Equivalent
K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K182648X5 Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K173921HD-500 Video Endoscope SystemNWBSubstantially Equivalent
K172993P20 Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K173058P10 Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K172082S60 Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K170999P50 Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K171000P60 Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K170303E5 Series Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K160283S45 Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K160258X5 Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K152854S50 Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K152396S12 Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K152165S9 Portable Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent

Registered establishments

FDA registered establishments for Sonoscape Medical Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30047056343004705634SONOSCAPE MEDICAL CORP.Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, SHENZHEN Guangdong 518057 CN2026
30155252403015525240SONOSCAPE MEDICAL CORP.SonoScape Medical Building, No.2 Road (West), Shuangming Blvd (South), Shenzhen Guangdong 518107 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain