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 a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2026-03-20 under approval 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. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K253520.
When was Photonova Spectra, Photonova Spectra Select approved by the FDA?
Photonova Spectra, Photonova Spectra Select received FDA 510(k) clearance on 2026-03-20, under approval number K253520.
What company makes Photonova Spectra, Photonova Spectra Select?
Photonova Spectra, Photonova Spectra Select is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for Photonova Spectra, Photonova Spectra Select?
The FDA product code for Photonova Spectra, Photonova Spectra Select is JAK.
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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.