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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 a medical device manufactured by Philips Image Guided Therapy Corporation. It received FDA 510(k) clearance on 2026-02-24 under approval 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. It is manufactured by Philips Image Guided Therapy Corporation. The 510(k) number is K253714.

When was IntraSight Plus approved by the FDA?

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

What company makes IntraSight Plus?

IntraSight Plus is manufactured by Philips Image Guided Therapy Corporation.

What is the FDA product code for IntraSight Plus?

The FDA product code for IntraSight Plus is IYO.

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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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