DVS (OPTION 01)— 510(k) K883101

Name: FDA 510(k) clearance K883101
Creator: U.S. Food and Drug Administration
Published: 1988-10-07

Substantially Equivalent

O.M.I. Oncology Microsystems, Inc.

FDA 510(k) clearance K883101 for DVS (OPTION 01), Substantially Equivalent on 1988-10-07. Applicant: O.M.I. Oncology Microsystems, Inc.. Device class: 2.

Clearance details

Applicant: O.M.I. Oncology Microsystems, Inc.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1988-07-22
Decision date: 1988-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

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K874214 — S9 DISPLAY SYSTEM1988-02-22

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.