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

FDA 510(k)

Philips CT Big Bore

K-Number: K171850 · 2017-11-09

Decision Date2017-11-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Philips CT Big Bore is a medical device manufactured by Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2017-11-09 under approval number K171850. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Philips CT Big Bore?

Philips CT Big Bore is a medical device that received FDA 510(k) clearance on 2017-11-09. It is manufactured by Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K171850.

When was Philips CT Big Bore approved by the FDA?

Philips CT Big Bore received FDA 510(k) clearance on 2017-11-09, under approval number K171850.

What company makes Philips CT Big Bore?

Philips CT Big Bore is manufactured by Philips Medical Systems (Cleveland), Inc..

What is the FDA product code for Philips CT Big Bore?

The FDA product code for Philips CT Big Bore is JAK.

Other Devices by Philips Medical Systems (Cleveland), Inc.

View all 7 devices →

Related Devices (Code: JAK)

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.