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)

Pinnacle Radiation Therapy Planning System

K-Number: K170086 · 2017-02-09

Decision Date2017-02-09
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Pinnacle Radiation Therapy Planning System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K170086. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pinnacle Radiation Therapy Planning System?

Pinnacle Radiation Therapy Planning System is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K170086.

When did Pinnacle Radiation Therapy Planning System receive FDA 510(k) clearance?

Pinnacle Radiation Therapy Planning System received FDA 510(k) clearance on 2017-02-09, under 510(k) number K170086.

Who is the listed applicant for Pinnacle Radiation Therapy Planning System?

The FDA 510(k) record lists Philips Medical Systems (Cleveland), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pinnacle Radiation Therapy Planning System?

The FDA product code for Pinnacle Radiation Therapy Planning System is MUJ.

Other records listing Philips Medical Systems (Cleveland), Inc. 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 7 devices →

Related Devices (Code: MUJ)

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.