510(k) Report

FDA applicant

Surgical Information Sciences, Inc.

Plymouth, MN7 decisions2017–20240 recalls

FDA records 7 decisions for Surgical Information Sciences, Inc. (Plymouth, MN) from 2017 to 2024: 7 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 56 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Surgical Information Sciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12019: 22021: 12022: 12023: 12024: 1
2017high 2 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Surgical Information Sciences, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgical Information Sciences, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological4decisions
  • QIHAutomated Radiological Image Processing Software3decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 56 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 5 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162830SIS SoftwareSurgical Information Sciences, Inc. · 20172cite it
  • K192304SIS Software Version 3.6.0Surgical Information Sciences, Inc. · 20191cites it
  • K230977SIS SystemSurgical Information Sciences, Inc. · 20231cites it
  • K223032SIS System (Version 5.6.0)Surgical Information Sciences, Inc. · 20221cites it
  • K210071SIS System (Version 5.1.0)Surgical Information Sciences, Inc. · 20211cites it
  • K183019SIS Software version 3.3.0Surgical Information Sciences, Inc. · 20191cites it

What has FDA decided for it lately?

  • K241083SIS SystemSurgical Information Sciences, Inc. · 2024
  • K230977SIS SystemSurgical Information Sciences, Inc. · 2023
  • K223032SIS System (Version 5.6.0)Surgical Information Sciences, Inc. · 2022
  • K210071SIS System (Version 5.1.0)Surgical Information Sciences, Inc. · 2021
  • K192304SIS Software Version 3.6.0Surgical Information Sciences, Inc. · 2019
  • K183019SIS Software version 3.3.0Surgical Information Sciences, Inc. · 2019
  • K162830SIS SoftwareSurgical Information Sciences, Inc. · 2017

All 7 as Surgical Information Sciences, Inc. →