SIS System (Version 5.6.0)— 510(k) K223032

Name: FDA 510(k) clearance K223032
Creator: U.S. Food and Drug Administration
Published: 2022-11-21

Substantially Equivalent

Surgical Information Sciences, Inc.

FDA 510(k) clearance K223032 for SIS System (Version 5.6.0), Substantially Equivalent on 2022-11-21. 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: 2022-09-29
Decision date: 2022-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ham Lake, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Surgical Information Sciences, Inc.

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K241083 — SIS System2024-06-14
K230977 — SIS System2023-05-02
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.