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FDA 510(k)

INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100

K-Number: K003853 · 2001-02-13

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2001-02-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 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 2001-02-13 under 510(k) number K003853. 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 INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100?

INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 is a medical device that received FDA 510(k) clearance on 2001-02-13. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K003853.

When did INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 receive FDA 510(k) clearance?

INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 received FDA 510(k) clearance on 2001-02-13, under 510(k) number K003853.

Who is the listed applicant for INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100?

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 INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100?

The FDA product code for INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 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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