VIEW ARCHIVING STATION— 510(k) K971176

Name: FDA 510(k) clearance K971176
Creator: U.S. Food and Drug Administration
Published: 1997-09-03

Substantially Equivalent

Electromed Intl., Ltd.

FDA 510(k) clearance K971176 for VIEW ARCHIVING STATION, Substantially Equivalent on 1997-09-03. Applicant: Electromed Intl., Ltd.. Device class: 2.

Clearance details

Applicant: Electromed Intl., Ltd.
Product code: Code IZI
Device class: Class 2
Regulation: 21 CFR 892.1600
Advisory panel: Radiology
Date received: 1997-03-31
Decision date: 1997-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Electromed Intl., Ltd.

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K003688 — VIEW READING STATION2001-01-22
K000474 — VIEW NT2000-04-19
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K974255 — CD-R STATION AND VRS-20001998-01-27
K950694 — COMPACT-X1995-03-31

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.