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FDA 510(k)

Deep Learning Image Reconstruction for Gemstone Spectral Imaging

K-Number: K201745 · 2020-12-10

ApplicantGe Medical Systems, LLC
Decision Date2020-12-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Deep Learning Image Reconstruction for Gemstone Spectral Imaging 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 2020-12-10 under 510(k) number K201745. 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 Deep Learning Image Reconstruction for Gemstone Spectral Imaging?

Deep Learning Image Reconstruction for Gemstone Spectral Imaging is a medical device that received FDA 510(k) clearance on 2020-12-10. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K201745.

When did Deep Learning Image Reconstruction for Gemstone Spectral Imaging receive FDA 510(k) clearance?

Deep Learning Image Reconstruction for Gemstone Spectral Imaging received FDA 510(k) clearance on 2020-12-10, under 510(k) number K201745.

Who is the listed applicant for Deep Learning Image Reconstruction for Gemstone Spectral Imaging?

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 Deep Learning Image Reconstruction for Gemstone Spectral Imaging?

The FDA product code for Deep Learning Image Reconstruction for Gemstone Spectral Imaging 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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