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

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..

Clearance details

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

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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.