IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK— 510(k) K010058

Substantially Equivalent

Witt Biomedical Corporation

FDA 510(k) clearance K010058 for IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK, Substantially Equivalent on 2001-03-21. Applicant: Witt Biomedical Corporation.

Clearance details

Applicant: Witt Biomedical Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2001-01-08
Decision date: 2001-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, 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.