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FDA 510(k)

PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)

K-Number: K940001 · 1995-11-14

ApplicantNucletron Corp.
Decision Date1995-11-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS) is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 1995-11-14 under 510(k) number K940001. 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-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)?

PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS) is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Nucletron Corp.. The 510(k) number is K940001.

When did PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS) receive FDA 510(k) clearance?

PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS) received FDA 510(k) clearance on 1995-11-14, under 510(k) number K940001.

Who is the listed applicant for PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)?

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

What is the FDA product code for PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)?

The FDA product code for PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS) is IYE.

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Other records listing Nucletron 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.

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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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