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)

Philips CT Big Bore

K-Number: K171850 · 2017-11-09

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2017-11-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Philips CT Big Bore 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 2017-11-09 under 510(k) 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. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K171850.

When did Philips CT Big Bore receive FDA 510(k) clearance?

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

Who is the listed applicant for Philips CT Big Bore?

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 Philips CT Big Bore?

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

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.

K172406Ingenuity TFK162838Philips iCT CT SystemK163711IQon Spectral CTK170086Pinnacle Radiation Therapy Planning SystemK160743Philips Ingenuity CTK153444Philips Multislice CT System with Low Dose CT Lung Cancer

View all 7 devices →

Related Devices (Code: JAK)

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.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

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.

↑