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FDA 510(k)

PHILIPS INTEGRIS 3D RA OPTION

K-Number: K983877 · 1998-12-21

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1998-12-21
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS INTEGRIS 3D RA OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 1998-12-21 under 510(k) number K983877. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS INTEGRIS 3D RA OPTION?

PHILIPS INTEGRIS 3D RA OPTION is a medical device that received FDA 510(k) clearance on 1998-12-21. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K983877.

When did PHILIPS INTEGRIS 3D RA OPTION receive FDA 510(k) clearance?

PHILIPS INTEGRIS 3D RA OPTION received FDA 510(k) clearance on 1998-12-21, under 510(k) number K983877.

Who is the listed applicant for PHILIPS INTEGRIS 3D RA OPTION?

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

What is the FDA product code for PHILIPS INTEGRIS 3D RA OPTION?

The FDA product code for PHILIPS INTEGRIS 3D RA OPTION is IZI.

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Other records listing Philips Medical Systems North America, Inc. as applicant

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.

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Related Devices (Code: IZI)

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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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