NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2— 510(k) K964206

Name: FDA 510(k) clearance K964206
Creator: U.S. Food and Drug Administration
Published: 1997-06-20

Substantially Equivalent

Nucletron Corp.

FDA 510(k) clearance K964206 for NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2, Substantially Equivalent on 1997-06-20. Applicant: Nucletron Corp.. Device class: 2.

Clearance details

Applicant: Nucletron Corp.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1996-10-21
Decision date: 1997-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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.