TumorSight Viz— 510(k) K251766

Substantially Equivalent

SimBioSys, Inc.

FDA 510(k) clearance K251766 for TumorSight Viz, Substantially Equivalent on 2025-07-08. Applicant: SimBioSys, Inc.. Device class: 2.

Clearance details

Applicant: SimBioSys, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-06-09
Decision date: 2025-07-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Chicago, IL, 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 SimBioSys, Inc.

K243189 — TumorSight Viz2024-10-25
K231130 — TumorSight Viz2023-12-26

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