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FDA 510(k)

IntelliSpace Radiology

K-Number: K182926 · 2018-12-06

ApplicantPhilips Healthcare Informatics, Inc.
Decision Date2018-12-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IntelliSpace Radiology is a medical device manufactured by Philips Healthcare Informatics, Inc.. It received FDA 510(k) clearance on 2018-12-06 under approval number K182926. 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 IntelliSpace Radiology?

IntelliSpace Radiology is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Philips Healthcare Informatics, Inc.. The 510(k) number is K182926.

When was IntelliSpace Radiology approved by the FDA?

IntelliSpace Radiology received FDA 510(k) clearance on 2018-12-06, under approval number K182926.

What company makes IntelliSpace Radiology?

IntelliSpace Radiology is manufactured by Philips Healthcare Informatics, Inc..

What is the FDA product code for IntelliSpace Radiology?

The FDA product code for IntelliSpace Radiology is LLZ.

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Official Source

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