Atlas FDA

OAS

135 FDA 510(k) clearances · Product code

113 daysmedian time to decision
268 days90th percentile
135clearances measured

FDA profile

Official device name
X-Ray, Tomography, Computed, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Medical specialty
Radiology
FDA definition
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Dental Cone-beam Computed Tomography (mDX-15P Series) (K261748)Hefei Meyer Optoelectronic Technology, Inc.2026-07-23
Dental X-ray System (K250839)Changzhou Boen Zhongding Medical Technology Co., Ltd.2026-06-11
Dental Cone Beam Computed Tomography System (K260662)Yofo Medical Technology Co., Ltd.2026-06-04
medXion NEXUS (K253935)medXion Technologies, Inc.2026-05-15
RCT800 (K260462)Ray Co., Ltd.2026-04-09
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (K260093)VATECH Co., Ltd.2026-03-31
myray ProXIma X6 (K252353)Cefla S.C.2026-03-10
Primevision 3D (K253959)Dentsply Sirona2026-02-05
RCT700 (K251798)Ray Co., Ltd.2025-11-25
Dental Computed Tomography X-ray System (K251842)Fussen Technology Co., Ltd.2025-11-13
GT300; GT300-C (K250060)Genoray Co., Ltd.2025-10-08
Dental CBCT X-ray System (K251642)Yian Medical Technology (Haining) Co., Ltd.2025-06-27
Dental Cone Beam Computed Tomography System (K243337)Yofo Medical Technology Co., Ltd.2025-04-17
RCT600 (K243903)Ray Co., Ltd.2025-03-12
Green X 12 SE (PHT-40CHS) (K243088)VATECH Co., Ltd.2025-02-21
Green X 21 (PHT-90CHO) (K243081)VATECH Co., Ltd.2025-02-14
Dental Cone-beam Computed Tomography (FinScan F350) (K242805)Changzhou Finno Medical Technology Co., Ltd.2025-01-09
Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) (K241249)Palodex Group OY2024-09-12
T2 Plus (K233806)Osstem Implant Co., Ltd.2024-09-06
Dental Cone-beam Computed Tomography (K240855)Yian Medical Technology (Haining) Co., Ltd.2024-04-25
Dental Cone-beam Computed Tomography (K232710)Yian Medical Technology (Haining) Co., Ltd.2024-01-09
Planmeca Viso (K230985)Planmeca Oy2023-12-28
bright CT (K231181)Dentium Co., Ltd (Ict Branch)2023-12-14
Provecta 3D Prime and Provecta 3D Prime Ceph (K232487)Durr Dental SE2023-09-14
PreXion3D Expedition (K232166)Prexion Corporation2023-09-08
RAYSCAN a-Expert3D (K232287)Ray Co., Ltd.2023-08-31
Grreen X 12 (Model: PHT-75CHS) (K231796)VATECH Co., Ltd.2023-07-19
X-View 3D Pan/X-View 2D Pan (K222666)Trident S.R.L2023-07-10
Orthopantomograph™ OP 3D LX (K230505)Palodex Group OY2023-06-09
RCT800 (K230753)Ray Co., Ltd.2023-04-11
Dental CT Scanner AXR (K223816)Alliage S/A Industrias Medico Odontológica2023-04-07
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K223794)Cefla S.C.2023-01-17
PreXion3D Expedition (K222150)Prexion Corporation2023-01-12
R2 Studio Q/RCT820 (K222219)Megagen Implant Co., Ltd.2022-12-06
PreXion3D Explorer PRO (K221525)Prexion Corporation2022-07-22
PAPAYA 3D & PAPAYA 3D Plus (K220392)Genoray Co., Ltd.2022-05-19
Planmed Verity (K213278)Planmed OY2022-04-28
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph (K213579)Fona S.R.L2022-03-02
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K214084)Cefla S.C.2022-01-20
eco-x Series (eco-x, eco-x-s) (K211159)Hdx Will Corp.2021-12-30
RCT700 (K213226)Ray Co., Ltd.2021-11-29
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) (K212254)Hdx Will Corp.2021-10-19
T2 (K212303)Osstem Implant Co., Ltd.2021-09-21
EAGLE EDGE AXR90 and AXR120 (K210820)Alliage S/A Industrias Medico Odontológica2021-08-10
rainbow MCT (K200270)Dentium Co., Ltd (Ict Branch)2021-04-16
rainbow CT (K200271)Dentium Co., Ltd (Ict Branch)2021-04-16
PreXion3D Explorer PRO (K203784)Prexion Corporation2021-02-23
Green X 18(Model : PHT-75CHS) (K210329)VATECH Co., Ltd.2021-02-18
3D Accuitomo 150N (K201378)J. Morita USA, Inc.2021-02-18
vatech A9 (Model : PHT-30CSS) (K203797)VATECH Co., Ltd.2021-01-25
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) (K201382)De Gotzen S.R.L.2020-11-18
Dental Computed Tomography X-Ray System, Green X (K201627)VATECH Co., Ltd.2020-10-27
PAPAYA 3D Premium & PAPAYA 3D Premium Plus (K200469)Genoray Co., Ltd.2020-09-16
Midmark Extraoral Imaging System (EOIS) (K201667)Midmark Corporation2020-08-06
Axeos (K201140)Dentsply Sirona2020-06-22
hyperion X5, NewTom GO, X-RADiUS COMPACT (K200688)Cefla S.C.2020-04-09
PreXion3D Explorer EX (K193329)Prexion Corporation2020-04-09
CS 9600 (K200183)Trophy2020-03-13
ProVecta 3D Prime Ceph (K193139)Durr Dental SE2020-03-05
RCT800 (K192737)Ray Co., Ltd.2019-10-22
SeeFactorCT3 (K190856)Epica International, Inc.2019-09-20
T1-CS, T1-C (K183475)Osstem Implant Co., Ltd.2019-08-30
Orthophos S (K191616)Dentsply Sirona2019-07-16
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K190496)Cefla S.C.2019-04-24
RAYSCAN a-Expert3D (K190812)Ray Co., Ltd.2019-04-24
PreXion3D Explorer (K190320)Prexion Corporation2019-04-15
RCT800 (K182805)Ray Co., Ltd.2018-12-14
Planmed Verity (K180918)Planmed OY2018-11-30
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) (K180601)Villa Sistemi Medicali S.P.A.2018-11-02
RCT700 (K182614)Ray Co., Ltd.2018-10-16
Planmeca Viso (K181576)Planmeca Oy2018-09-13
PreXion 3D Excelsior (K181983)Prexion Corporation2018-08-17
ProVectra 3D Prime with VistaSoft (K181432)Durr Dental SE2018-08-02
RCT800 (K181452)Ray Co., Ltd.2018-07-27
Orthopantomograph OP 3D (K180947)Palodex Group OY2018-06-07
CS 9600 (K181136)Trophy2018-05-24
PreXion3D Excelsior (K173878)Prexion Corporation2018-01-19
Veraview X800 (K171012)J. Morita USA, Inc.2017-12-19
Orthopantomograph OP300 (K163423)Palodex Group OY2017-08-31
Green16/Green18 (Model: PHT-65LHS) (K170066)VATECH Co., Ltd.2017-06-16
ORTHOPANTOMOGRAPH OP 3D (K170813)Palodex Group OY2017-04-07
HYPERION X5 (K161900)Cefla S.C.2016-12-09
X-MIND trium (K160166)De Gotzen S.R.L.2016-11-15
i-CAT FLX V series / KaVo 3D eXam+ V series (K162085)Imaging Sciences International2016-11-10
PaX-i3D Green Premium (Model: PCT-90LH) (K160882)VATECH Co., Ltd.2016-10-28
Green Smart (Model: PHT-35LHS) (K162660)VATECH Co., Ltd.2016-10-20
PreXion3D Excelsior (K161881)Prexion Corporation2016-10-03
DENTRIa series (K160140)Hdx Will Corp.2016-09-30
RCT700 (K160525)Ray Co., Ltd.2016-06-20
X-VIEW, IMAGEN (K151137)Edlen Imaging, LLC2016-06-07
Planmeca ProMax 3D Max, Planmeca Maximity (K160506)Planmeca Oy2016-05-20
NewTom VGi evo (K151612)Qr S.R.L.2016-03-31
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray (K152489)Panoramic Corp.2016-02-04
PAPAYA 3D Plus (K150354)Genoray Co., Ltd.2015-12-10
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart (K152106)VATECH Co., Ltd.2015-10-23
Planmed Verity (K143435)Planmed OY2015-05-14
ORTHOPHOS SL (K150217)Sirona Dental Systems GmbH2015-05-08
RAYSCAN A-EXPERT 3D (K142247)Ray Co., Ltd.2015-04-17
QMASTER-H/REVO (K133797)Telesystems Co., Ltd.2014-09-04
TON-95LH, PAX-I3D ORTHO (K132983)VATECH Co., Ltd.2014-08-07
Next →

Track OAS automatically

Every clearance here is in the API, with alerts when new ones post.