SIS Software

K162830

Surgical Information Sciences, Inc. · cleared 2017-02-14 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing and visualization.”
Algorithmmachine learning and image processing
source quote (p.4)
“SIS Software uses machine learning and image processing to enhance standard clinical images for the visualization of the subthalamic nucleus (“STN”).”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=10 patients

endpoints: average distance between the predicted and the original (on the 7T); overlap between the 3D predicted and the original STN

Retrospective clinical

n=34 patients

endpoints: Center of mass distance; Surface distance; Dice coefficient values

Reported performance (1 observation)

diceas written: “Dice coefficient”0.64
source quote (p.6)
“In addition, the Dice coefficient in this dataset was 0.64, which was expected given the small size of the STN.”

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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
32
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K210071 (decision 2021-03-31) from Surgical Information Sciences, Inc. for a matching device line ("SIS System (Version 5.1.0)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K210071

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K192304 (decision 2019-09-13) from Surgical Information Sciences, Inc. for a matching device line ("SIS Software Version 3.6.0") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K192304

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K183019 (decision 2019-03-19) from Surgical Information Sciences, Inc. for a matching device line ("SIS Software version 3.3.0") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K183019

  • …and 26 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K162830