DEL-IMS— 510(k) K063188

Substantially Equivalent

Del Medical Imaging Corp.

FDA 510(k) clearance K063188 for DEL-IMS, Substantially Equivalent on 2006-11-30. Applicant: Del Medical Imaging Corp..

Clearance details

Applicant: Del Medical Imaging Corp.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-10-20
Decision date: 2006-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.