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FDA 510(k)

Achieva 1.5T, 3.0T and Intera 1.5T MR Systems

K-Number: K190461 · 2019-06-04

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2019-06-04
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Achieva 1.5T, 3.0T and Intera 1.5T MR Systems is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2019-06-04 under approval number K190461. 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 Achieva 1.5T, 3.0T and Intera 1.5T MR Systems?

Achieva 1.5T, 3.0T and Intera 1.5T MR Systems is a medical device that received FDA 510(k) clearance on 2019-06-04. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K190461.

When was Achieva 1.5T, 3.0T and Intera 1.5T MR Systems approved by the FDA?

Achieva 1.5T, 3.0T and Intera 1.5T MR Systems received FDA 510(k) clearance on 2019-06-04, under approval number K190461.

What company makes Achieva 1.5T, 3.0T and Intera 1.5T MR Systems?

Achieva 1.5T, 3.0T and Intera 1.5T MR Systems is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Achieva 1.5T, 3.0T and Intera 1.5T MR Systems?

The FDA product code for Achieva 1.5T, 3.0T and Intera 1.5T MR Systems 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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