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

Name: FDA 510(k) clearance K901422
Creator: U.S. Food and Drug Administration
Published: 1990-08-21

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.. Device class: 2.

Clearance details

Applicant: Image Systems, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
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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K913755 — STATVIEW1991-11-19
K844771 — INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM1985-02-27

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.