510(k) Report

FDA applicant

Medison America, Inc.

Pleasanton, CA21 decisions1993–20036 recalls

FDA records 21 decisions for Medison America, Inc. (Pleasanton, CA) from 1993 to 2003: 21 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 27 predicates, 22 of them its own earlier devices. 6 recalls are 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 Medison America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medison America, Inc. since 2007.

Recalls per year

5in 2008

2008: 5
2007high 5 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medison America, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medison America, Inc.’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, Ultrasonic10decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic9decisions
  • ITXTransducer, Ultrasonic, Diagnostic2decisions

Whose devices does it build on?

Its devices cite 27 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 52 times; 22 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.

  • K003525Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 200010cite it
  • K974269SA8800 Diagnostic Ultrasound System and Transducers,Medison America, Inc. · 19988cite it
  • K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 20016cite it
  • K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 20005cite it
  • K974813Combison 530D with Power Doppler ModeMedison America, Inc. · 19983cite it
  • K000030Sonoace 600 Diagnostic Ultrasound SystemMedison America, Inc. · 20003cite it

What has FDA decided for it lately?

  • K032329SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
  • K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 20035 recalls
  • K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
  • K012887SA6000II Diagnostic Ultrasound SystemMedison America, Inc. · 2001
  • K012867Sonoace 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
  • K003525Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
  • K003121Mysono 201 Diagnostic Ultrasound and TransducersMedison America, Inc. · 2000
  • K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 20001 recall

All 21 as Medison America, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K031552Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound…Aug 12, 2008
  • K031552Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System…Aug 12, 2008
  • K031552Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for…May 29, 2008
  • K031552Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for…May 29, 2008
  • K031552Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for…May 29, 2008
  • K002185HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).Sep 10, 2004

Other applicant names beginning “Medison”

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

Medison Co., Ltd. 24Medison Radiology Systems, Inc. 2