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FDA 510(k)

PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511

K-Number: K091195 · 2009-05-27

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2009-05-27
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 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 2009-05-27 under 510(k) number K091195. 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 MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511?

PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 is a medical device that received FDA 510(k) clearance on 2009-05-27. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K091195.

When did PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 receive FDA 510(k) clearance?

PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 received FDA 510(k) clearance on 2009-05-27, under 510(k) number K091195.

Who is the listed applicant for PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511?

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 MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511?

The FDA product code for PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 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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