Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Shantou Institute of Ultrasonic Instuments · Predicate Candidate Screening

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

164 daysmedian FDA review time
295 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K113613DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEMShantou Institute of Ultrasonic Instuments2012-06-151920
K092907DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, Shantou Institute of Ultrasonic Instuments2010-03-051640
K081110SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEMShantou Institute of Ultrasonic Instuments2008-05-16280
K070982CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEMShantou Institute of Ultrasonic Instuments2007-05-02260
K061083CTS-7700Shantou Institute of Ultrasonic Instuments2006-06-06490
K013327CTS-415Shantou Institute of Ultrasonic Instuments2001-12-14700
K012772CTS-485 ULTRASOUND IMAGING SYSTEMShantou Institute of Ultrasonic Instuments2001-10-01450
K984203SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEMShantou Institute of Ultrasonic Instuments1999-11-013420
K984161CTS-310(B)Shantou Institute of Ultrasonic Instuments1999-05-051660
K963065CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERSShantou Institute of Ultrasonic Instuments1997-05-292950
K963068CTS-200 WITH EZU-PL21 TRANSDUCERShantou Institute of Ultrasonic Instuments1997-05-292950

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