FDI 2000 ULTRASONIC SKIN SCANNER— 510(k) K902965

Substantially Equivalent

Fulmer Dyson Intl.

FDA 510(k) clearance K902965 for FDI 2000 ULTRASONIC SKIN SCANNER, Substantially Equivalent on 1990-09-26. Applicant: Fulmer Dyson Intl..

Clearance details

Applicant: Fulmer Dyson Intl.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1990-07-06
Decision date: 1990-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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.