ULTRASCAN(R)— 510(k) K896173

Substantially Equivalent

Topical Delivery Systems

FDA 510(k) clearance K896173 for ULTRASCAN(R), Substantially Equivalent on 1990-04-11. Applicant: Topical Delivery Systems.

Clearance details

Applicant: Topical Delivery Systems
Product code: Code IYO
Advisory panel: Radiology
Date received: 1989-10-25
Decision date: 1990-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hartland, WI, 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.