FDA 510(k)

Philips CT Big Bore Sliding Gantry Configuration

Numéro K : K181797 · 2018-08-03

DemandeurPhillips Medical Systems (Cleveland), Inc.

Date de décision2018-08-03

Code produitJAK

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : JAK)

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Source officielle

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