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

Dublin, CA, US

Sonoscape Company Limited appears in FDA device records in Dublin, CA. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
22
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 22 510(k) clearances for Sonoscape Company Limited between 2004 and 2015. The busiest year on record is 2013, with 7. The most recent is 2015, with 4.

Clearances by year, as a table
510(k) clearance decisions for Sonoscape Company Limited, by decision year
YearClearances
20042
20051
20102
20114
20121
20137
20141
20154
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K150045S30/S40 Digital Color Doppler Ultraound SystemIYNSubstantially Equivalent
K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K142815S22 Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K142710S9 Portable Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K142474S12 Digital Color Doppler Ultrasound SystemIYNSubstantially Equivalent
K132527DIGITAL COLOR DOPPLER ULTASOUND SYSTEMIYNSubstantially Equivalent
K131262DIGITAL ELECTROCARDIOGRAPHSDPSSubstantially Equivalent
K132768S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYNSubstantially Equivalent
K131213DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYNSubstantially Equivalent
K130801DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYNSubstantially Equivalent
K131088PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYNSubstantially Equivalent
K130119PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYNSubstantially Equivalent
K123616PORTABLE ULTRASONIC DIAGNOSTIC SYSTEMIYOSubstantially Equivalent
K112602S6 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially Equivalent
K112451S8 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially Equivalent
K110510S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMIYNSubstantially Equivalent
K102642SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICROIYNSubstantially Equivalent
K101337A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEMIYOSubstantially Equivalent
K092922SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCERIYNSubstantially Equivalent
K052042SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERSIYNSubstantially Equivalent
K042369SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000IYNSubstantially Equivalent
K041455SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMIYOSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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