DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)— 510(k) K973081

Substantially Equivalent

Howtek, Inc.

FDA 510(k) clearance K973081 for DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0), Substantially Equivalent on 1997-11-05. Applicant: Howtek, Inc..

Clearance details

Applicant: Howtek, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1997-08-18
Decision date: 1997-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NH, 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.