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FDA 510(k)

Deep Learning Image Reconstruction

K-Number: K230807 · 2023-04-20

ApplicantGe Healthcare Japan Corporation
Decision Date2023-04-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Deep Learning Image Reconstruction is a medical device manufactured by Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2023-04-20 under approval number K230807. 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 2023-04-20. It is manufactured by Ge Healthcare Japan Corporation. The 510(k) number is K230807.

When was Deep Learning Image Reconstruction approved by the FDA?

Deep Learning Image Reconstruction received FDA 510(k) clearance on 2023-04-20, under approval number K230807.

What company makes Deep Learning Image Reconstruction?

Deep Learning Image Reconstruction is manufactured by Ge Healthcare Japan Corporation.

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)

Other Devices by Ge Healthcare Japan Corporation

K193170Deep Learning Image Reconstruction K203169Revolution Ascend K212067Deep Learning Image Reconstruction K220961Deep Learning Image Reconstruction K213938Revolution Ascend K233698True Enhance DL

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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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