SMARTPACS FILMLESS READING AND IMAGE DISTRIBUTION SYSTEM AND CONSULTATION STATION— 510(k) K941093

Substantially Equivalent

Smartpacs

FDA 510(k) clearance K941093 for SMARTPACS FILMLESS READING AND IMAGE DISTRIBUTION SYSTEM AND CONSULTATION STATION, Substantially Equivalent on 1994-11-07. Applicant: Smartpacs.

Clearance details

Applicant: Smartpacs
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1994-03-08
Decision date: 1994-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Simi Valley, 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.