AiMIFY (1.x)
K240290Subtle Medical, Inc. · cleared 2024-08-21 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The AiMIFY device is a software as a medical device consisting of a machine learning software algorithm that enhances images taken by MRI scanners.”
source quote (p.6)
“AiMIFY consists of a software algorithm that improves contrast-to-noise ratio (CNR), contrast enhancement (CEP), and lesion-to-brain ratio (LBR) of Gadolinium-Based Contrast Agent (GBCA) enhanced T1-weighted images while maintaining diagnostic performance, using deep learning technology. AiMIFY image processing software uses a convolutional neural network based algorithm to enhance the AiMIFY-contrast images from pre-contrast and standard-dose post-contrast images. AIMIFY processes the input image in a 2.5D fashion using a UNet style neural network.”
source quote (p.8)
“Improved generalizability of the AiMIFY AI/ML model is expected to affect the labeled limitations of AiMIFY, as the model will be more generalizable than the cleared version of the device. Improvements planned include additional training and/or performance data to add more gadolinium-based contrast agents, add additional patient ages (infants and children), add additional clinical conditions, and add additional scanner models. The AiMIFY AI/ML model is planned to be retrained with additional output channels to reduce processing time, and shall be subject to the same performance testing endpoints and acceptance criteria as the cleared version of the device.”
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
source quote (p.6)
“The AiMIFY device itself is not networked and therefore does not increase the cybersecurity risk of its users. Users are provided cybersecurity recommendations in labeling.”
Validation studies (2)
Retrospective clinical
n=95 cases
endpoints: Contrast Enhancement Percentage (CEP); Contrast-to-Noise Ratio (CNR); Lesion-to-Brain Ratio (LBR); CNR, LBR, and CEP of a selected region of interest (ROI) in each test dataset is on average improved by greater than or equal to 50% after AiMIFY enhancement compared to the traditionally acquired contrast images
Reader study (MRMC)
n=95 cases
endpoints: Perceived Visibility of Lesion Contrast Enhancement; Lesion Border Delineation; Lesion Internal Morphology; Perceived Image Quality; Artifact Presence; Vessel Conspicuity
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97993
- …and 20 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).