VisAble.IO— 510(k) K240773

Substantially Equivalent

Techsomed

FDA 510(k) clearance K240773 for VisAble.IO, Substantially Equivalent on 2024-04-15. Applicant: Techsomed. Device class: 2.

Clearance details

Applicant: Techsomed
Product code: Code QTZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-03-21
Decision date: 2024-04-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QTZ

K253264 — myAblation Guide (VC10A)2026-06-16
K252947 — HistoSonics® Planning Tool2026-05-29
K251931 — BioTraceIO Vision (V1.7)2025-09-08
K240796 — myAblation Guide (VB80A)2024-08-06
K222222 — Artemis, Artemis TPO, Artemis MX2023-10-12

More clearances from Techsomed

K223639 — VisAble.IO2023-08-28

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