VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH— 510(k) K802434

Substantially Equivalent

Varian Assoc., Inc.

FDA 510(k) clearance K802434 for VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH, Substantially Equivalent on 1981-02-19. Applicant: Varian Assoc., Inc..

Clearance details

Applicant: Varian Assoc., Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1980-10-06
Decision date: 1981-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.