SIS System (Version 5.1.0)

K210071

Surgical Information Sciences, Inc. · cleared 2021-03-31 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The SIS System version 5.1.0, a software only device based on machine learning and image processing, is designed to enhance standard clinical images for the visualization of structures in the basal ganglia area of the brain, specifically the subthalamic nucleus (STN) and globus pallidus externa and interna (GPe/GPi).”

Algorithmmachine learning and image processing, deep learning neural network models, deep learning Convolutional Neural Network models

source quote (p.5)

“The SIS System version 5.1.0, a software only device based on machine learning and image processing, is designed to enhance standard clinical images for the visualization of structures in the basal ganglia area of the brain, specifically the subthalamic nucleus (STN) and globus pallidus externa and interna (GPe/GPi). The SIS System version 5.1.0 provides a patient-specific, 3D anatomical model of specific brain structures based on the patient's own clinical MR image using pre-trained deep learning neural network models. The proposed device is a modification to the SIS Software version 3.6.0 that was cleared under K192304. The changes made to the SIS System include (1) an updated algorithm that is based on deep learning Convolutional Neural Network models that were architected and optimized for brain image segmentation;”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (5)

Retrospective clinical

sample size not stated

endpoints: visualization accuracy

Bench

sample size not stated

endpoints: 3D transformation accuracy

Bench

sample size not stated

Bench

sample size not stated

endpoints: lead segmentation

Retrospective clinical

n=43 images

endpoints: trusted detection being accurate (within ± 30° of the ground truth); untrusted detection being accurate; orientations presented to the user are accurate within ± 30°

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

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K241083 (decision 2024-06-14) from Surgical Information Sciences, Inc. for a matching device line ("SIS System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241083
re_clearance
The FDA AI/ML device list shows a newer 510(k) K230977 (decision 2023-05-02) from Surgical Information Sciences, Inc. for a matching device line ("SIS System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K230977
re_clearance
The FDA AI/ML device list shows a newer 510(k) K223032 (decision 2022-11-21) from Surgical Information Sciences, Inc. for a matching device line ("SIS System (Version 5.6.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K223032
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
…and 23 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).