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FDA 510(k)

DUFFUSION-WEIGHTED MR IMAGING PACKAGE

K-Number: K974530 · 1998-02-06

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1998-02-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DUFFUSION-WEIGHTED MR IMAGING PACKAGE 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 1998-02-06 under 510(k) number K974530. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUFFUSION-WEIGHTED MR IMAGING PACKAGE?

DUFFUSION-WEIGHTED MR IMAGING PACKAGE is a medical device that received FDA 510(k) clearance on 1998-02-06. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K974530.

When did DUFFUSION-WEIGHTED MR IMAGING PACKAGE receive FDA 510(k) clearance?

DUFFUSION-WEIGHTED MR IMAGING PACKAGE received FDA 510(k) clearance on 1998-02-06, under 510(k) number K974530.

Who is the listed applicant for DUFFUSION-WEIGHTED MR IMAGING PACKAGE?

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 DUFFUSION-WEIGHTED MR IMAGING PACKAGE?

The FDA product code for DUFFUSION-WEIGHTED MR IMAGING PACKAGE is LNH.

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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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