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FDA 510(k)

Deep Learning Image Reconstruction

K-Number: K183202 · 2019-04-12

ApplicantGe Medical Systems, LLC
Decision Date2019-04-12
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Deep Learning Image Reconstruction is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2019-04-12 under approval number K183202. 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 2019-04-12. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K183202.

When was Deep Learning Image Reconstruction approved by the FDA?

Deep Learning Image Reconstruction received FDA 510(k) clearance on 2019-04-12, under approval number K183202.

What company makes Deep Learning Image Reconstruction?

Deep Learning Image Reconstruction is manufactured by Ge Medical Systems, LLC.

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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Related PubMed Literature

PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025)

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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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