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FDA 510(k)

PLATO RADIATION THERAPY PLANNING SYSTEM

K-Number: K921991 · 1992-11-27

ApplicantNucletron-Oldelft Corp.
Decision Date1992-11-27
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PLATO RADIATION THERAPY PLANNING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron-Oldelft Corp.. It received FDA 510(k) clearance on 1992-11-27 under 510(k) number K921991. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATO RADIATION THERAPY PLANNING SYSTEM?

PLATO RADIATION THERAPY PLANNING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-11-27. The listed applicant is Nucletron-Oldelft Corp.. The 510(k) number is K921991.

When did PLATO RADIATION THERAPY PLANNING SYSTEM receive FDA 510(k) clearance?

PLATO RADIATION THERAPY PLANNING SYSTEM received FDA 510(k) clearance on 1992-11-27, under 510(k) number K921991.

Who is the listed applicant for PLATO RADIATION THERAPY PLANNING SYSTEM?

The FDA 510(k) record lists Nucletron-Oldelft Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLATO RADIATION THERAPY PLANNING SYSTEM?

The FDA product code for PLATO RADIATION THERAPY PLANNING SYSTEM is IYE.

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Other records listing Nucletron-Oldelft Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953946MICROSELECTRON-HDR VERSION 2K953831N 800 HFK925956MICROSELECTRON - HDR FOR MOBILE ENVIRONMENTK926407MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILMK915622PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEMK911612NUCLETRON PLANNING SYSTEM

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Related Devices (Code: IYE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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