FDA 510(k)

EZ-FIDUCIALS

K-Number: K250505 · 2025-07-09

Decision Date2025-07-09

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EZ-FIDUCIALS is the device name listed in this FDA 510(k) record. The listed applicant is Phasor Health, LLC. It received FDA 510(k) clearance on 2025-07-09 under 510(k) number K250505. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-FIDUCIALS?

EZ-FIDUCIALS is a medical device that received FDA 510(k) clearance on 2025-07-09. The listed applicant is Phasor Health, LLC. The 510(k) number is K250505.

When did EZ-FIDUCIALS receive FDA 510(k) clearance?

EZ-FIDUCIALS received FDA 510(k) clearance on 2025-07-09, under 510(k) number K250505.

Who is the listed applicant for EZ-FIDUCIALS?

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

What is the FDA product code for EZ-FIDUCIALS?

The FDA product code for EZ-FIDUCIALS is HAW.

Other records listing Phasor Health, 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.

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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.