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FDA 510(k)

EVAC-MRI

K-Number: K252514 · 2025-11-05

ApplicantPhasor Health, LLC
Decision Date2025-11-05
Product CodeJXG
Advisory CommitteeNE
DecisionUnknown

Device Summary

EVAC-MRI 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 2025-11-05 under 510(k) number K252514. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EVAC-MRI?

EVAC-MRI is a medical device that received FDA 510(k) clearance on 2025-11-05. The listed applicant is Phasor Health, LLC. The 510(k) number is K252514.

When did EVAC-MRI receive FDA 510(k) clearance?

EVAC-MRI received FDA 510(k) clearance on 2025-11-05, under 510(k) number K252514.

Who is the listed applicant for EVAC-MRI?

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 EVAC-MRI?

The FDA product code for EVAC-MRI is JXG.

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.

K252696LEGACYK252060GREENK250505EZ-FIDUCIALSK243205EVAC

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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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