PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50— 510(k) K010472

Name: FDA 510(k) clearance K010472
Creator: U.S. Food and Drug Administration
Published: 2001-05-08

Substantially Equivalent

Thomson & Nielsen Electronics, Ltd.

FDA 510(k) clearance K010472 for PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50, Substantially Equivalent on 2001-05-08. Applicant: Thomson & Nielsen Electronics, Ltd.. Device class: 2.

Clearance details

Applicant: Thomson & Nielsen Electronics, Ltd.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2001-02-20
Decision date: 2001-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, Ontario, CA

Download summary PDF View on FDA.gov ↗

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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.