SIS System (Version 5.6.0)

K223032

Surgical Information Sciences, Inc. · cleared 2022-11-21 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“The SIS System version 5.6.0 is a software only device based on machine learning and image processing.”

Algorithmpre-trained deep learning neural network models

source quote (p.5)

“The SIS System version 5.6.0 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. These pre-trained deep learning neural network models are then applied to a patient's clinical image to predict the shape and position of the patient's specific brain structures of interest.”

Adaptive (vs locked)No

source quote (p.5)

“These pre-trained deep learning neural network models are then applied to a patient's clinical image to predict the shape and position of the patient's specific brain structures of interest.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: validate that the software functions as specified and performs similarly to the predicate device; validate visualization of the STN and GPi/GPe structures; ensure that 3D transformation remains accurate; validate the lead segmentation; validate the lead detection functionality

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

MAUDE reports in code, 12mo

—

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

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).