Medical Device Manufacturer · US , Flintville , TN

Genoray Co., Ltd. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 2007

Recent clearances: BELLIGER ACE, GT300, HESTIA

Official Website

24

Total

24

Cleared

0

Denied

FDA 510(k) Regulatory Record - Genoray Co., Ltd. Radiology ✕

24 devices

1-12 of 24

Cleared Apr 02, 2026

Radiology · 260d

Cleared Oct 08, 2025

Radiology · 271d

Cleared Jul 17, 2025

Radiology · 255d

Cleared Dec 08, 2023

DVAS (DVAS-M, DVAS-W)

Radiology · 148d

Cleared Sep 13, 2023

Radiology · 55d

Cleared Jul 20, 2023

Oscar 15 & Oscar 15i

Radiology · 120d

Cleared May 19, 2022

PAPAYA 3D & PAPAYA 3D Plus

Radiology · 97d

Cleared May 19, 2022

PAPAYA & PAPAYA Plus

Radiology · 94d

Cleared Mar 09, 2022

Radiology · 273d

Cleared Sep 16, 2020

PAPAYA 3D Premium & PAPAYA 3D Premium Plus

Radiology · 203d

Cleared Aug 17, 2018

OSCAR (OSCAR Prime, OSCAR Classic)

Radiology · 28d

Cleared Mar 07, 2018

Radiology · 170d