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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 a medical device manufactured by Phillips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2018-08-03 under approval 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. It is manufactured by Phillips Medical Systems (Cleveland), Inc.. The 510(k) number is K181797.

When was Philips CT Big Bore Sliding Gantry Configuration approved by the FDA?

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

What company makes Philips CT Big Bore Sliding Gantry Configuration?

Philips CT Big Bore Sliding Gantry Configuration is manufactured by Phillips Medical Systems (Cleveland), Inc..

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.

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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.

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