OUR ROTATING GAMMA SYSTEM— 510(k) K970647

Name: FDA 510(k) clearance K970647
Creator: U.S. Food and Drug Administration
Published: 1997-05-20

Substantially Equivalent

Our Scientific Intl., Inc.

FDA 510(k) clearance K970647 for OUR ROTATING GAMMA SYSTEM, Substantially Equivalent on 1997-05-20. Applicant: Our Scientific Intl., Inc.. Device class: 2.

Clearance details

Applicant: Our Scientific Intl., Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 1997-02-20
Decision date: 1997-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWB

view all

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 Our Scientific Intl., Inc.

view all

K991815 — EXPLORER 3D1999-08-13

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