FDA applicant

Quantum Intl.

Issaquah, WA1 decision1990–19900 recalls

FDA records 1 decision for Quantum Intl. (Issaquah, WA) in 1990: 1 510(k) clearance. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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 Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quantum Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Quantum”

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

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

Quantum Intl.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Quantum”