510(k) Report

FDA applicant

Shantou Institute of Ultrasonic Instuments

Walnut Creek, CA11 decisions1997–20120 recalls

FDA records 11 decisions for Shantou Institute of Ultrasonic Instuments (Walnut Creek, CA) from 1997 to 2012: 11 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 13 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Shantou Institute of Ultrasonic Instuments’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12008: 12010: 12012: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shantou Institute of Ultrasonic Instuments by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shantou Institute of Ultrasonic…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic8decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic3decisions

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012772CTS-485 Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 20012cite it
  • K113613Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 20122cite it
  • K061083CTS-7700Shantou Institute of Ultrasonic Instuments · 20061cites it
  • K070982CTS-7700 Digital Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 20071cites it
  • K092907Digital Ultrasound Imaging System, Convex Array Transducer, Linear Array Transducer, Convex Array…Shantou Institute of Ultrasonic Instuments · 20101cites it

What has FDA decided for it lately?

  • K113613Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2012
  • K092907Digital Ultrasound Imaging System, Convex Array Transducer, Linear Array Transducer, Convex Array…Shantou Institute of Ultrasonic Instuments · 2010
  • K081110Siui CTS-900 Digital Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2008
  • K070982CTS-7700 Digital Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2007
  • K061083CTS-7700Shantou Institute of Ultrasonic Instuments · 2006
  • K013327CTS-415Shantou Institute of Ultrasonic Instuments · 2001
  • K012772CTS-485 Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2001
  • K984203Siui Apogee 800PLUS Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 1999

All 11 as Shantou Institute of Ultrasonic Instuments →

Other applicant names beginning “Shantou”

FDA records each applicant name separately; these may or may not be the same firm.

Shantou Institute of Ultrasonic Instruments Co., Ltd.… 8Shantou Wealy Medical Instrument Co.,Ltd 6Shantou Institute of Ultrasonic Instruments (Siui 5Shantou Institute of Ultrasonic Instruments Co., Ltd. 3Shantou Xinghe Electrical Apparatuses Co., Ltd. 2Shantou Huihengqi Electronic Technology Co., Ltd. 1Shantou T&K Medical Equipment Factory Co.,Ltd 1