Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sonoscape Company Limited · Predicate Candidate Screening

22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

86 daysmedian FDA review time
170 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited2015-04-281060
K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystSonoscape Company Limited2015-01-291290
K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited2015-01-281210
K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited2015-01-051050
K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited2014-12-191070
K132527DIGITAL COLOR DOPPLER ULTASOUND SYSTEMSonoscape Company Limited2013-11-14940
K131262DIGITAL ELECTROCARDIOGRAPHSSonoscape Company Limited2013-11-141950
K132768S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMSonoscape Company Limited2013-10-04300
K131213DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMSonoscape Company Limited2013-06-21530
K130801DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMSonoscape Company Limited2013-06-14840
K131088PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMSonoscape Company Limited2013-05-24360
K130119PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMSonoscape Company Limited2013-04-12860
K123616PORTABLE ULTRASONIC DIAGNOSTIC SYSTEMSonoscape Company Limited2012-12-21280
K112602S6 DIAGNOSTIC ULTRASOUND SYSTEMSonoscape Company Limited2011-11-07610
K112451S8 DIAGNOSTIC ULTRASOUND SYSTEMSonoscape Company Limited2011-09-16220
K110510S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMSonoscape Company Limited2011-05-16830
K102642SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, Sonoscape Company Limited2011-03-041720
K101337A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEMSonoscape Company Limited2010-09-301410
K092922SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 Sonoscape Company Limited2010-03-121700
K052042SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERSSonoscape Company Limited2005-08-09120
K042369SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000Sonoscape Company Limited2004-10-20500
K041455SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMSonoscape Company Limited2004-06-1090

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda