HDX DIGITAL IMAGING SYSTEM— 510(k) K954055

Substantially Equivalent

Imacom, Inc.

FDA 510(k) clearance K954055 for HDX DIGITAL IMAGING SYSTEM, Substantially Equivalent on 1995-10-24. Applicant: Imacom, Inc..

Clearance details

Applicant: Imacom, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1995-08-29
Decision date: 1995-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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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.