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FDA 510(k)

Interventional Workspot

K-Number: K181177 · 2018-05-31

Decision Date2018-05-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Interventional Workspot 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 2018-05-31 under 510(k) number K181177. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Interventional Workspot?

Interventional Workspot is a medical device that received FDA 510(k) clearance on 2018-05-31. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K181177.

When did Interventional Workspot receive FDA 510(k) clearance?

Interventional Workspot received FDA 510(k) clearance on 2018-05-31, under 510(k) number K181177.

Who is the listed applicant for Interventional Workspot?

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 Interventional Workspot?

The FDA product code for Interventional Workspot is LLZ.

Other records listing Philips Medical Systems Nederland B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.