Akesis Galaxy— 510(k) K190844

Substantially Equivalent

Akesis, Inc.

FDA 510(k) clearance K190844 for Akesis Galaxy, Substantially Equivalent on 2019-09-04. Applicant: Akesis, Inc.. Device class: 2.

Clearance details

Applicant: Akesis, Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2019-04-01
Decision date: 2019-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWB

K250391 — Leksell Gamma Knife® (3 models)2025-07-02
K232854 — Leksell GammaPlan (LGP)2024-02-08
K222047 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)2022-10-26
K203250 — TaiChiC2021-03-12
K203146 — Akesis Galaxy RTi2021-03-05

More clearances from Akesis, Inc.

K200050 — Akesis Galaxy RTx2020-02-04

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