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FDA 510(k)

2D Quantitative Analysis

K-Number: K161839 · 2016-07-29

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2016-07-29
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

2D Quantitative Analysis is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-07-29 under approval number K161839. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2D Quantitative Analysis?

2D Quantitative Analysis is a medical device that received FDA 510(k) clearance on 2016-07-29. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K161839.

When was 2D Quantitative Analysis approved by the FDA?

2D Quantitative Analysis received FDA 510(k) clearance on 2016-07-29, under approval number K161839.

What company makes 2D Quantitative Analysis?

2D Quantitative Analysis is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for 2D Quantitative Analysis?

The FDA product code for 2D Quantitative Analysis is OWB.

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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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