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 Sliding Gantry Configuration

K-Number: K181797 · 2018-08-03

ApplicantPhillips Medical Systems (Cleveland), Inc.
Decision Date2018-08-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Philips CT Big Bore Sliding Gantry Configuration is the device name listed in this FDA 510(k) record. The listed applicant is Phillips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K181797. 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 Sliding Gantry Configuration?

Philips CT Big Bore Sliding Gantry Configuration is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Phillips Medical Systems (Cleveland), Inc.. The 510(k) number is K181797.

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

Philips CT Big Bore Sliding Gantry Configuration received FDA 510(k) clearance on 2018-08-03, under 510(k) number K181797.

Who is the listed applicant for Philips CT Big Bore Sliding Gantry Configuration?

The FDA 510(k) record lists Phillips 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 Sliding Gantry Configuration?

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

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.

↑