SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE— 510(k) K891452

Substantially Equivalent

Diasonics, Inc.

FDA 510(k) clearance K891452 for SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE, Substantially Equivalent on 1989-06-07. Applicant: Diasonics, Inc..

Clearance details

Applicant: Diasonics, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1989-03-15
Decision date: 1989-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milipitas, CA, US

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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.