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FDA 510(k)

Lumify Diagnostic Ultrasound System

K-Number: K252558 · 2026-05-05

Decision Date2026-05-05
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lumify Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2026-05-05 under 510(k) number K252558. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumify Diagnostic Ultrasound System?

Lumify Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2026-05-05. The listed applicant is Philips Ultrasound, LLC. The 510(k) number is K252558.

When did Lumify Diagnostic Ultrasound System receive FDA 510(k) clearance?

Lumify Diagnostic Ultrasound System received FDA 510(k) clearance on 2026-05-05, under 510(k) number K252558.

Who is the listed applicant for Lumify Diagnostic Ultrasound System?

The FDA 510(k) record lists Philips Ultrasound, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumify Diagnostic Ultrasound System?

The FDA product code for Lumify Diagnostic Ultrasound System is IYN.

Other records listing Philips Ultrasound, LLC 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.

View all 45 devices →

Related Devices (Code: IYN)

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

View on FDA Database →

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