ADAC XL-PLAN-PC— 510(k) K920041

Substantially Equivalent

Adac Laboratories

FDA 510(k) clearance K920041 for ADAC XL-PLAN-PC, Substantially Equivalent on 1992-03-30. Applicant: Adac Laboratories.

Clearance details

Applicant: Adac Laboratories
Product code: Code IYE
Advisory panel: Radiology
Date received: 1992-01-06
Decision date: 1992-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.