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 a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2023-03-09 under approval 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. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K223514.
When was Spectral Bone Marrow approved by the FDA?
Spectral Bone Marrow received FDA 510(k) clearance on 2023-03-09, under approval number K223514.
What company makes Spectral Bone Marrow?
Spectral Bone Marrow is manufactured by Ge Medical Systems, LLC.
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.