QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES— 510(k) K853217

Name: FDA 510(k) clearance K853217
Creator: U.S. Food and Drug Administration
Published: 1985-12-30

Substantially Equivalent

Quantum Medical Systems, Inc.

FDA 510(k) clearance K853217 for QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES, Substantially Equivalent on 1985-12-30. Applicant: Quantum Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Quantum Medical Systems, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1985-08-01
Decision date: 1985-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issaquah, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.