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FDA 510(k)

IntraSight Plus

K-Number: K253714 · 2026-02-24

ApplicantPhilips Image Guided Therapy Corporation
Decision Date2026-02-24
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IntraSight Plus is the device name listed in this FDA 510(k) record. The listed applicant is Philips Image Guided Therapy Corporation. It received FDA 510(k) clearance on 2026-02-24 under 510(k) number K253714. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntraSight Plus?

IntraSight Plus is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is Philips Image Guided Therapy Corporation. The 510(k) number is K253714.

When did IntraSight Plus receive FDA 510(k) clearance?

IntraSight Plus received FDA 510(k) clearance on 2026-02-24, under 510(k) number K253714.

Who is the listed applicant for IntraSight Plus?

The FDA 510(k) record lists Philips Image Guided Therapy Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntraSight Plus?

The FDA product code for IntraSight Plus is IYO.

Other records listing Philips Image Guided Therapy Corporation as applicant

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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.

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