Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Accuray Precision Treatment Planning System

K-Number: K171086 · 2017-06-08

Decision Date2017-06-08
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Accuray Precision Treatment Planning System is the device name listed in this FDA 510(k) record. The listed applicant is Accuray Incorporated. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K171086. 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 Accuray Precision Treatment Planning System?

Accuray Precision Treatment Planning System is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Accuray Incorporated. The 510(k) number is K171086.

When did Accuray Precision Treatment Planning System receive FDA 510(k) clearance?

Accuray Precision Treatment Planning System received FDA 510(k) clearance on 2017-06-08, under 510(k) number K171086.

Who is the listed applicant for Accuray Precision Treatment Planning System?

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

What is the FDA product code for Accuray Precision Treatment Planning System?

The FDA product code for Accuray Precision Treatment Planning System is IYE.

Other records listing Accuray Incorporated 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.

View all 9 devices →

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.

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.