SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF— 510(k) K901422

Substantially Equivalent

Image Systems, Inc.

FDA 510(k) clearance K901422 for SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF, Substantially Equivalent on 1990-08-21. Applicant: Image Systems, Inc..

Clearance details

Applicant: Image Systems, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1990-03-26
Decision date: 1990-08-21
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.