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FDA 510(k)

Deep Learning Image Reconstruction

K-Number: K213999 · 2022-02-18

ApplicantGe Medical Systems, LLC
Decision Date2022-02-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Deep Learning Image Reconstruction 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 2022-02-18 under 510(k) number K213999. 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?

Deep Learning Image Reconstruction is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K213999.

When did Deep Learning Image Reconstruction receive FDA 510(k) clearance?

Deep Learning Image Reconstruction received FDA 510(k) clearance on 2022-02-18, under 510(k) number K213999.

Who is the listed applicant for Deep Learning Image Reconstruction?

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?

The FDA product code for Deep Learning Image Reconstruction 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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