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FDA 510(k)

Deep Learning Image Reconstruction

K-Number: K212067 · 2021-09-17

ApplicantGe Healthcare Japan Corporation
Decision Date2021-09-17
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 Healthcare Japan Corporation. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K212067. 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 2021-09-17. The listed applicant is Ge Healthcare Japan Corporation. The 510(k) number is K212067.

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

Deep Learning Image Reconstruction received FDA 510(k) clearance on 2021-09-17, under 510(k) number K212067.

Who is the listed applicant for Deep Learning Image Reconstruction?

The FDA 510(k) record lists Ge Healthcare Japan Corporation 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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Other records listing Ge Healthcare Japan Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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