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FDA 510(k)

Photonova Spectra, Photonova Spectra Select

K-Number: K253520 · 2026-03-20

ApplicantGe Medical Systems, LLC
Decision Date2026-03-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Photonova Spectra, Photonova Spectra Select is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K253520. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Photonova Spectra, Photonova Spectra Select?

Photonova Spectra, Photonova Spectra Select is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K253520.

When did Photonova Spectra, Photonova Spectra Select receive FDA 510(k) clearance?

Photonova Spectra, Photonova Spectra Select received FDA 510(k) clearance on 2026-03-20, under 510(k) number K253520.

Who is the listed applicant for Photonova Spectra, Photonova Spectra Select?

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

What is the FDA product code for Photonova Spectra, Photonova Spectra Select?

The FDA product code for Photonova Spectra, Photonova Spectra Select is JAK.

Other records listing Ge Medical Systems, LLC as applicant

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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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