SIS System— 510(k) K230977

Substantially Equivalent

Surgical Information Sciences, Inc.

FDA 510(k) clearance K230977 for SIS System, Substantially Equivalent on 2023-05-02. 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: 2023-04-05
Decision date: 2023-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Edina, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

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K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Surgical Information Sciences, Inc.

K241083 — SIS System2024-06-14
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.