510(k) Report

FDA applicant

Quantum Medical Systems, Inc.

Issaquah, WA5 decisions1985–19910 recalls

FDA records 5 decisions for Quantum Medical Systems, Inc. (Issaquah, WA) from 1985 to 1991: 5 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and MAA (Monitor, Fetal Doppler Ultrasound). 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 Quantum Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quantum Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic3decisions
  • MAAMonitor, Fetal Doppler Ultrasound1decision
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K904019Quantum 2000 Angiodynograph Ultrasound SystemQuantum Medical Systems, Inc. · 19911cites it

What has FDA decided for it lately?

  • K904019Quantum 2000 Angiodynograph Ultrasound SystemQuantum Medical Systems, Inc. · 1991
  • K894992Quantum Qad Angiodynograph Ultrasound SystemQuantum Medical Systems, Inc. · 1990
  • K890998Qad Angiodynograph Ultrasound: Color Doppler Eval.Quantum Medical Systems, Inc. · 1989
  • K860581Qad-1 Angiodynograph Ultrasound SystemQuantum Medical Systems, Inc. · 1987
  • K853217Qad-1 Angio Dynograph Ultraso W/5.0 7.5 MHZ ProbesQuantum Medical Systems, Inc. · 1985

All 5 as Quantum Medical Systems, Inc. →

Other applicant names beginning “Quantum”

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

Quantum Orthopedics, Inc. 6Quantum Medical Imaging, LLC 5Quantum Bioengineering, Ltd. 4Quantum Co., Ltd. 3Quantum Medical Concepts, LLC 2Quantum Instruments Corp. 2Quantum Surgical Sas 2Quantum Devices, Inc. 2Quantum Skincare, Inc. 1Quantum Intl. 1Quantum Medical Imaging Divison of Carestream 1Quantum Life Systems, Inc. 1