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FDA 510(k)

EZ-FIDUCIALS

K-Number: K250505 · 2025-07-09

ApplicantPhasor Health, LLC
Decision Date2025-07-09
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EZ-FIDUCIALS is a medical device manufactured by Phasor Health, LLC. It received FDA 510(k) clearance on 2025-07-09 under approval 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. It is manufactured by Phasor Health, LLC. The 510(k) number is K250505.

When was EZ-FIDUCIALS approved by the FDA?

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

What company makes EZ-FIDUCIALS?

EZ-FIDUCIALS is manufactured by Phasor Health, LLC.

What is the FDA product code for EZ-FIDUCIALS?

The FDA product code for EZ-FIDUCIALS is HAW.

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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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