Radiology · 510(k) · 2021
MaxFOV 2
GE Medical Systems, LLC.. Cleared by FDA on 2 March 2021 under submission K203617, product code JAK (system, x-ray, tomography, computed). What FDA's record says, in FDA's words.
Device record · K203617
- Device. MaxFOV 2DEVICE
- Company. GE Medical Systems, LLC.COMPANY
- Decision. 2 March 2021, 510(k), substantially equivalent (traditional review); received 11 December 2020DECISION
- Panel. RadiologyPANEL
- Product code. JAK, System, X-Ray, Tomography, ComputedCODE
- Regulation. 21 CFR 892.1750, Class IIREG
- Source. FDA database entry · decision document (7 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.
The deep learning based Max Field-of-View (MaxFOV 2) is a CT image reconstruction method intended to produce images of the head and whole-body using Axial, Helical, and Cine acquisitions. MaxFOV 2 is designed to extend the nominal display field of view (DFoV) for cases where patient size and positioning requirements result in a portion of the patient’s body to be outside of the nominal DFoV. These extended FoV images are intended for use in radiation therapy planning and are clinically useful for the simulation and planning of radiation therapy for the treatment of cancer for patients. They can also be used for visualization of patient anatomy for cases not involving therapy planning. MaxFOV 2 is intended for patients of all ages, especially bariatric patients.
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
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 2021. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.