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FDA 510(k)

INTEGRIS 3D-RA, RELEASE 4.2

K-Number: K040254 · 2004-02-19

ApplicantPhilips Medical Systems North America Co.
Decision Date2004-02-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTEGRIS 3D-RA, RELEASE 4.2 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America Co.. It received FDA 510(k) clearance on 2004-02-19 under 510(k) number K040254. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRIS 3D-RA, RELEASE 4.2?

INTEGRIS 3D-RA, RELEASE 4.2 is a medical device that received FDA 510(k) clearance on 2004-02-19. The listed applicant is Philips Medical Systems North America Co.. The 510(k) number is K040254.

When did INTEGRIS 3D-RA, RELEASE 4.2 receive FDA 510(k) clearance?

INTEGRIS 3D-RA, RELEASE 4.2 received FDA 510(k) clearance on 2004-02-19, under 510(k) number K040254.

Who is the listed applicant for INTEGRIS 3D-RA, RELEASE 4.2?

The FDA 510(k) record lists Philips Medical Systems North America Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGRIS 3D-RA, RELEASE 4.2?

The FDA product code for INTEGRIS 3D-RA, RELEASE 4.2 is LLZ.

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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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