Radiology · 510(k) · 2020
Deep Learning Image Reconstruction for Gemstone Spectral Imaging
GE Medical Systems, LLC. Cleared by FDA on 10 December 2020 under submission K201745, product code JAK (system, x-ray, tomography, computed). What FDA's record says, in FDA's words.
Device record · K201745
- Device. Deep Learning Image Reconstruction for Gemstone Spectral ImagingDEVICE
- Company. GE Medical Systems, LLCCOMPANY
- Decision. 10 December 2020, 510(k), substantially equivalent (traditional review); received 26 June 2020DECISION
- Panel. RadiologyPANEL
- Product code. JAK, System, X-Ray, Tomography, ComputedCODE
- Regulation. 21 CFR 892.1750, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Deep Learning Image Reconstruction for Gemstone Spectral Imaging (GSI_DLIR) 4-1 FORM FDA 3881 (7/17) PSC Publishing Services (301) 443-6740 EF DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. Name Deep Learning Image Reconstruction for Gemstone Spectral Imaging Indications for Use (Describe) The Deep Learning Image Reconstruction for Gemstone Spectral Imaging option is a deep learning based CT reconstruction method intended to produce cross-sectional images by computer reconstruction of dual energy X-ray transmission data acquired with Gemstone Spectral Imaging, for all ages. Deep Learning Image Reconstruction for Gemstone Spectral Imaging can be used for whole body, vascular, and contrast enhanced head CT applications.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, radiographs (X-ray)
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 5,281 reports filed against devices carrying product code JAK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
25 September 2026 · Malfunction · REVOLUTION EVO · GE MEDICAL SYSTEMS, LLC · report 50896044
The GE CT table wouldn't move during stroke. Patient had to be physically moved to resume scan, delay in care. GE CT table has had the same issues with the table working intermittently x 3 weeks. Multiple techs have worked on it and the same problem persists.
25 September 2026 · Malfunction · Needle Guide · Quantum Surgical SAS · report 3023140882-2026-00002
23 September 2026 · Malfunction · ILLUMISITE · COVIDIEN LP - SUPERDIMENSION INC · report 3004962788-2026-00087
It was reported that during the procedure, one locatable guide indicated as outside of the sensor sensing volume and another locatable guide had difficulty retracting from the extended working channel. The physician completed the superDimension portion of the case. No patient complications have been reported as a result of this event.
23 September 2026 · Other · NL4000 · Samsung HME America, Inc. · report 3004938766-2026-00043
23 September 2026 · Malfunction · ILLUMISITE · COVIDIEN LP - SUPERDIMENSION INC · report 3004962788-2026-00088
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code JAK, in Radiology, from GE Medical Systems, LLC, or cleared in 2020. The whole record is at FDA AI-enabled medical devices.
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