MITRA IMAGING INC. EXHIBIT— 510(k) K982769

Substantially Equivalent

Mitra Imaging, Inc.

FDA 510(k) clearance K982769 for MITRA IMAGING INC. EXHIBIT, Substantially Equivalent on 1998-11-03. Applicant: Mitra Imaging, Inc..

Clearance details

Applicant: Mitra Imaging, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1998-08-07
Decision date: 1998-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, 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.