MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1— 510(k) K012227

Substantially Equivalent

Oncology Data Systems, Inc.

FDA 510(k) clearance K012227 for MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1, Substantially Equivalent on 2001-10-01. Applicant: Oncology Data Systems, Inc..

Clearance details

Applicant: Oncology Data Systems, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2001-07-16
Decision date: 2001-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Download summary PDF View on FDA.gov ↗

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.