Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2020-12-10 under approval 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. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K201745.

When was Deep Learning Image Reconstruction for Gemstone Spectral Imaging approved by the FDA?

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

What company makes Deep Learning Image Reconstruction for Gemstone Spectral Imaging?

Deep Learning Image Reconstruction for Gemstone Spectral Imaging is manufactured by Ge Medical Systems, LLC.

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.

Related Clinical Trials

NCT06561828 Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making RECRUITING NCT05707806 Development and Validation of Learning and Decision-Making Tasks RECRUITING NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT05145426 Investigation of Low-intensity Focused Ultrasound for Human Pain Management COMPLETED NCT06492252 Speech Motor Learning and Retention (Aim 3) RECRUITING

Related PubMed Literature

PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 41153261 From Lab to Clinic: Artificial Intelligence with Spectroscopic Liquid Biopsies. Diagnostics (Basel, Switzerland) (2025) PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025)

Other Devices by Ge Medical Systems, LLC

K163213Revolution CT K162403HyperBand K162990Optima XR240amx K161397MAGiC K161574Discovery MI K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T

View all 42 devices →

Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.

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.

↑