ClearanceBrief
Company ยท KR

Ray Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.

24510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
OASX-Ray, Tomography, Computed, Dental15
MUHSystem, X-Ray, Extraoral Source, Digital5
FXXMask, Surgical1
LLZSystem, Image Processing, Radiological1
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)1
PNNOrthodontic Software1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 9, 2026K260462RCT800
Ray Co., Ltd., KR
OAS
Nov 25, 2025K251798RCT700
Ray Co., Ltd., KR
OAS
May 21, 2025K251109SMARTDent
Ray Co., Ltd., KR
LLZ
Mar 12, 2025K243903RCT600
Ray Co., Ltd., KR
OAS
May 16, 2024K233625RAYDENT SW
Ray Co., Ltd., KR
PNN
Apr 18, 2024K232325RAYSCAN a-Expert
Ray Co., Ltd., KR
MUH
Aug 31, 2023K232287RAYSCAN a-Expert3D
Ray Co., Ltd., KR
OAS
Apr 11, 2023K230753RCT800
Ray Co., Ltd., KR
OAS
Nov 29, 2021K213226RCT700
Ray Co., Ltd., KR
OAS
May 17, 2021K211105Ear-Friendly Mask
Ray Co., Ltd., KR
FXX
Oct 22, 2019K192737RCT800
Ray Co., Ltd., KR
OAS
Apr 24, 2019K190812RAYSCAN a-Expert3D
Ray Co., Ltd., KR
OAS
Dec 14, 2018K182805RCT800
Ray Co., Ltd., KR
OAS
Oct 16, 2018K182614RCT700
Ray Co., Ltd., KR
OAS
Jul 27, 2018K181452RCT800
Ray Co., Ltd., KR
OAS
Jun 20, 2016K160525RCT700
Ray Co., Ltd., KR
OAS
Apr 15, 2016K160788RIOScan (RPS500)
Ray Co., Ltd., KR
MUH
Apr 22, 2015K142058RAYSCAN A-EXPERT
Ray Co., Ltd.
MUH
Apr 17, 2015K142247RAYSCAN A-EXPERT 3D
Ray Co., Ltd., KR
OAS
Jan 23, 2015K143000RIS500
Ray Co., Ltd., KR
MQB
Nov 1, 2013K131695RAYSCAN A-EXPERT 3D
Ray Co., Ltd.
OAS
Nov 1, 2013K131693RAYSCAN A-EXPERT
Ray Co., Ltd.
MUH
Mar 15, 2013K122918RAYSCAN A-EXPERT
Ray Co., Ltd.
MUH
Mar 12, 2013K122981RAYSCAN A-EXPERT 3D
Ray Co., Ltd.
OAS

Latest recalls

DateFirm and productCodeLinked 510(k)
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