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FDA 510(k)

Spectral Bone Marrow

K-Number: K223514 · 2023-03-09

ApplicantGe Medical Systems, LLC
Decision Date2023-03-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Spectral Bone Marrow 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 2023-03-09 under 510(k) number K223514. 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 Spectral Bone Marrow?

Spectral Bone Marrow is a medical device that received FDA 510(k) clearance on 2023-03-09. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K223514.

When did Spectral Bone Marrow receive FDA 510(k) clearance?

Spectral Bone Marrow received FDA 510(k) clearance on 2023-03-09, under 510(k) number K223514.

Who is the listed applicant for Spectral Bone Marrow?

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 Spectral Bone Marrow?

The FDA product code for Spectral Bone Marrow 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.

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