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FDA 510(k)

ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING

K-Number: K963451 · 1997-08-05

ApplicantTopslane
Decision Date1997-08-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING is the device name listed in this FDA 510(k) record. The listed applicant is Topslane. It received FDA 510(k) clearance on 1997-08-05 under 510(k) number K963451. 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 ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING?

ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING is a medical device that received FDA 510(k) clearance on 1997-08-05. The listed applicant is Topslane. The 510(k) number is K963451.

When did ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING receive FDA 510(k) clearance?

ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING received FDA 510(k) clearance on 1997-08-05, under 510(k) number K963451.

Who is the listed applicant for ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING?

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

What is the FDA product code for ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING?

The FDA product code for ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING is IYE.

Related Clinical Trials

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)

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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Official Source

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

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