Medical Device Manufacturer · US , Beverly Hills , CA

Ray Co., Ltd.

23 submissions · 23 cleared · Since 2013
23
Total
23
Cleared
0
Denied

Ray Co., Ltd. — FDA 510(k) Submissions

Ray Co., Ltd. has submitted 23 FDA 510(k) premarket notifications since 2013, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include X-ray, Tomography, Computed, Dental, System, X-ray, Extraoral Source, Digital, System, Image Processing, Radiological, Solid State X-ray Imager (flat Panel/digital Imager), Mask, Surgical . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
RCT700
K251798 · OAS X-ray, Tomography,... · Radiology
Nov 2025 166d
SMARTDent
K251109 · LLZ System, Image Processing,... · Radiology
May 2025 40d
RCT600
K243903 · OAS X-ray, Tomography,... · Radiology
Mar 2025 83d
RAYDENT SW
K233625 · PNN Orthodontic Software · Dental
May 2024 185d
RAYSCAN a-Expert
K232325 · MUH System, X-ray, Extraoral... · Radiology
Apr 2024 259d
RAYSCAN a-Expert3D
K232287 · OAS X-ray, Tomography,... · Radiology
Aug 2023 30d
RCT800
K230753 · OAS X-ray, Tomography,... · Radiology
Apr 2023 25d
RCT700
K213226 · OAS X-ray, Tomography,... · Radiology
Nov 2021 61d
Ear-Friendly Mask
K211105 · FXX Mask, Surgical · General Hospital
May 2021 34d
RCT800
K192737 · OAS X-ray, Tomography,... · Radiology
Oct 2019 25d
RAYSCAN a-Expert3D
K190812 · OAS X-ray, Tomography,... · Radiology
Apr 2019 26d
RCT800
K182805 · OAS X-ray, Tomography,... · Radiology
Dec 2018 73d
RCT700
K182614 · OAS X-ray, Tomography,... · Radiology
Oct 2018 25d
RCT800
K181452 · OAS X-ray, Tomography,... · Radiology
Jul 2018 56d
RCT700
K160525 · OAS X-ray, Tomography,... · Radiology
Jun 2016 116d
RIOScan (RPS500)
K160788 · MUH System, X-ray, Extraoral... · Radiology
Apr 2016 24d
RAYSCAN A-EXPERT
K142058 · MUH System, X-ray, Extraoral... · Radiology
Apr 2015 267d
RAYSCAN A-EXPERT 3D
K142247 · OAS X-ray, Tomography,... · Radiology
Apr 2015 262d
RIS500
K143000 · MQB Solid State X-ray Imager... · Radiology
Jan 2015 98d
RAYSCAN A-EXPERT
K131693 · MUH System, X-ray, Extraoral... · Radiology
Nov 2013 144d
RAYSCAN A-EXPERT 3D
K131695 · OAS X-ray, Tomography,... · Radiology
Nov 2013 144d
RAYSCAN A-EXPERT
K122918 · MUH System, X-ray, Extraoral... · Radiology
Mar 2013 172d
RAYSCAN A-EXPERT 3D
K122981 · OAS X-ray, Tomography,... · Radiology
Mar 2013 169d
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