SIS System— 510(k) K241083

Substantially Equivalent

Surgical Information Sciences, Inc.

FDA 510(k) clearance K241083 for SIS System, Substantially Equivalent on 2024-06-14. Applicant: Surgical Information Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Surgical Information Sciences, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-04-19
Decision date: 2024-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Surgical Information Sciences, Inc.

K230977 — SIS System2023-05-02
K223032 — SIS System (Version 5.6.0)2022-11-21
K210071 — SIS System (Version 5.1.0)2021-03-31
K192304 — SIS Software Version 3.6.02019-09-13
K183019 — SIS Software version 3.3.02019-03-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.