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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) 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. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K161839.

When did 2D Quantitative Analysis receive FDA 510(k) clearance?

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

Who is the listed applicant for 2D Quantitative Analysis?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

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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