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Panels › Radiology › Product code OAS · Class 2

X-Ray, Tomography, Computed, Dental

Regulation 892.1750

11510(k)s in 12 months (136 all time)
3recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in OAS

Company510(k)sRecalls
VATECH Co., Ltd.190
Ray Co., Ltd.150
Palodex Group OY81
Prexion Corporation90
Cefla S.C.70
Osstem Implant Co., Ltd.33
Trophy41
Genoray Co., Ltd.40
Dentium Co., Ltd (Ict Branch)30
Dentsply Sirona30
Decided510(k)Device and applicantCode
Jan 25, 2021K203797vatech A9 (Model : PHT-30CSS)
VATECH Co., Ltd., KR
OAS
Nov 18, 2020K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
De Gotzen S.R.L., IT
OAS
Oct 27, 2020K201627Dental Computed Tomography X-Ray System, Green X
VATECH Co., Ltd., KR
OAS
Sep 16, 2020K200469PAPAYA 3D Premium & PAPAYA 3D Premium Plus
Genoray Co., Ltd., KR
OAS
Aug 6, 2020K201667Midmark Extraoral Imaging System (EOIS)
Midmark Corporation
OAS
Jun 22, 2020K201140Axeos
Dentsply Sirona
OAS
Apr 9, 2020K200688hyperion X5, NewTom GO, X-RADiUS COMPACT
Cefla S.C., IT
OAS
Apr 9, 2020K193329PreXion3D Explorer EX
Prexion Corporation, JP
OAS
Mar 13, 2020K200183CS 9600
Trophy, FR
OAS
Mar 5, 2020K193139ProVecta 3D Prime Ceph
Durr Dental SE, DE
OAS
Oct 22, 2019K192737RCT800
Ray Co., Ltd., KR
OAS
Sep 20, 2019K190856SeeFactorCT3
Epica International, Inc.
OAS
Aug 30, 2019K183475T1-CS, T1-C
Osstem Implant Co., Ltd., KR
OAS
Jul 16, 2019K191616Orthophos S
Dentsply Sirona
OAS
Apr 24, 2019K190812RAYSCAN a-Expert3D
Ray Co., Ltd., KR
OAS
Apr 24, 2019K190496hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
Cefla S.C., IT
OAS
Apr 15, 2019K190320PreXion3D Explorer
Prexion Corporation, JP
OAS
Dec 14, 2018K182805RCT800
Ray Co., Ltd., KR
OAS
Nov 30, 2018K180918Planmed Verity
Planmed OY, FI
OAS
Nov 2, 2018K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
Villa Sistemi Medicali S.P.A., IT
OAS
Oct 16, 2018K182614RCT700
Ray Co., Ltd., KR
OAS
Sep 13, 2018K181576Planmeca Viso
Planmeca Oy, FI
OAS
Aug 17, 2018K181983PreXion 3D Excelsior
Prexion Corporation, JP
OAS
Aug 2, 2018K181432ProVectra 3D Prime with VistaSoft
Durr Dental SE, DE
OAS
Jul 27, 2018K181452RCT800
Ray Co., Ltd., KR
OAS
Jun 7, 2018K180947Orthopantomograph OP 3D
Palodex Group OY, FI
OAS
May 24, 2018K181136CS 9600
Trophy, FR
OAS
Jan 19, 2018K173878PreXion3D Excelsior
Prexion Corporation, JP
OAS
Dec 19, 2017K171012Veraview X800
J. Morita USA, Inc.
OAS
Aug 31, 2017K163423Orthopantomograph OP300
Palodex Group OY, FI
OAS
Jun 16, 2017K170066Green16/Green18 (Model: PHT-65LHS)
VATECH Co., Ltd., KR
OAS
Apr 7, 2017K170813ORTHOPANTOMOGRAPH OP 3D
Palodex Group OY, FI
OAS
Dec 9, 2016K161900HYPERION X5
Cefla S.C., IT
OAS
Nov 15, 2016K160166X-MIND trium
De Gotzen S.R.L., IT
OAS
Nov 10, 2016K162085i-CAT FLX V series / KaVo 3D eXam+ V series
Imaging Sciences International
OAS
Oct 28, 2016K160882PaX-i3D Green Premium (Model: PCT-90LH)
VATECH Co., Ltd., KR
OAS
Oct 20, 2016K162660Green Smart (Model: PHT-35LHS)
VATECH Co., Ltd., KR
OAS
Oct 3, 2016K161881PreXion3D Excelsior
Prexion Corporation, JP
OAS
Sep 30, 2016K160140DENTRIa series
Hdx Will Corp., KR
OAS
Jun 20, 2016K160525RCT700
Ray Co., Ltd., KR
OAS
Jun 7, 2016K151137X-VIEW, IMAGEN
Edlen Imaging, LLC
OAS
May 20, 2016K160506Planmeca ProMax 3D Max, Planmeca Maximity
Planmeca Oy, FI
OAS
Mar 31, 2016K151612NewTom VGi evo
Qr S.R.L., IT
OAS
Feb 4, 2016K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
Panoramic Corp.
OAS
Dec 10, 2015K150354PAPAYA 3D Plus
Genoray Co., Ltd., KR
OAS
Oct 23, 2015K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
VATECH Co., Ltd., KR
OAS
May 14, 2015K143435Planmed Verity
Planmed OY, FI
OAS
May 8, 2015K150217ORTHOPHOS SL
Sirona Dental Systems GmbH, DE
OAS
Apr 17, 2015K142247RAYSCAN A-EXPERT 3D
Ray Co., Ltd., KR
OAS
Sep 4, 2014K133797QMASTER-H/REVO
Telesystems Co., Ltd.
OAS

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