System, X-Ray, Extraoral Source, Digital

FDA product code MUH · 186 cleared devices

Class 2 Dental

Regulation: 21 CFR 872.1800
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1998-10-22 – 2026-03-03

MUH 2026-03-03

SOTA Cloud Smart Sensor (1.5)

Applicant Sota Cloud Corp.

K number K251793

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MUH 2025-11-10

EzSensor HD, EzSensor UHD

Applicant Qpix Solutions, Inc.

K number K252570

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MUH 2025-10-24

Cocoon Solo (DX-7020s)

Applicant Dexcowin Global, Inc.

K number K250687

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MUH 2025-09-24

Digital X-Ray DentiMax Pro Imaging System

Applicant Dentimax, Inc.

K number K251206

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MUH 2024-10-25

VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)

Applicant VATECH Co., Ltd.

K number K240040

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MUH 2024-10-11

X Sensor (Model: IOS-A15IF, HDI-15DGF)

Applicant Qpix Solutions, Inc.

K number K242778

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MUH 2024-07-05

DUO1 and DUO2

Applicant Zinnovi, Inc.

K number K241649

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MUH 2024-04-18

RAYSCAN a-Expert

Applicant Ray Co., Ltd.

K number K232325

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MUH 2023-12-20

Digital image scanner of dental

Applicant Jiangsu Dynamic Medical Technology Co., Ltd.

K number K231660

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MUH 2023-11-21

DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor

Applicant Dental Imaging Technologies Corporation

K number K233053

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MUH 2023-10-20

TuxDeluxe (Size 1 6100B, Size 2 6101B)

Applicant Tuxedo Imaging, LLC

K number K232552

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MUH 2023-10-20

Digital Wireless Intraoral X-Ray Sensor

Applicant Iray Imaging Technology (Haining) Limited

K number K230998

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MUH 2023-10-10

WeSensor

Applicant Picopack, Inc.

K number K230916

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MUH 2023-09-27

EZSensor XHD

Applicant Qpix Solutions, Inc.

K number K232255

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MUH 2023-09-13

GenX-CR

Applicant Genoray Co., Ltd.

K number K232158

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MUH 2023-06-22

QuickRayPRO

Applicant Denterprise International, Inc.

K number K231202

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MUH 2023-04-21

Digital Intraoral X-Ray Sensor

Applicant Iray Imaging Technology (Haining) Limited

K number K230811

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MUH 2023-04-11

Eagle S/Saevo Slim/D700 Slim

Applicant Alliage S/A Industrias Medica Odontológico.

K number K230732

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MUH 2023-02-06

ScanX Swift 2.0, ScanX Swift View 2.0

Applicant Durr Dental SE

K number K230095

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MUH 2022-08-31

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20

Applicant Realcloud Imaging Inc. Dba Realcloud Imaging

K number K221955

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MUH 2022-06-22

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

Applicant Shanghai Handy Medical Equipment Co., Ltd.

K number K221008

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MUH 2022-05-19

PAPAYA & PAPAYA Plus

Applicant Genoray Co., Ltd.

K number K220423

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MUH 2022-04-13

OpenSensorX Series

Applicant Dentimax, Inc.

K number K220556

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MUH 2022-03-11

Dental sensors NanoPix1, NanoPix2

Applicant Iray Technology Taicang , Ltd.

K number K220422

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MUH 2022-03-02

Dental Image Plate Scanner, Model DFC-4T-SMART

Applicant Hefei Dentafilm Medical Equipment Co., Ltd.

K number K214091

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MUH 2022-02-17

Digital Intraoral X-ray Sensor

Applicant Shenzhen Xpectvision Technology Co., Ltd.

K number K220277

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MUH 2021-12-10

JAZZ Solo sensor

Applicant Jazz Imaging, LLC Dba Jazz Imaging

K number K213637

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MUH 2021-10-07

Digital Intraoral X-ray Imaging System

Applicant Iray Technology Taicang , Ltd.

K number K212279

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MUH 2021-09-27

Imaging Plate Scanner, i-Scan

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K number K212080

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MUH 2021-09-15

RXS 1000

Applicant Rolence Enterprise, Inc.

K number K202369

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MUH 2021-08-30

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2

Applicant Fona S.R.L

K number K212103

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MUH 2021-07-29

CRUXVIEW

Applicant Cruxell Corp.

K number K211317

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MUH 2021-07-22

DC-Air and Athlos-1 and Athlos-Air

Applicant Athlos OY

K number K211688

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MUH 2021-04-23

PlutoX Digital Intraoral X-Ray Imaging System

Applicant Iray Technology Taicang , Ltd.

K number K210312

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MUH 2021-03-19

SensorX

Applicant Durr Dental SE

K number K203116

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MUH 2021-02-05

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)

Applicant De Götzen S.R.L.

K number K203374

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MUH 2020-11-06

Clio Prime and Clio Pedo

Applicant Sota Precision Optics, Inc. Dba Sota Imaging

K number K202664

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MUH 2020-10-07

ScanX Edge

Applicant Dürr Dental SE

K number K202633

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MUH 2020-04-15

I-View Gold and Imagen Gold Dental Sensors

Applicant Trident S.R.L

K number K200625

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MUH 2020-02-28

R-Sensor, R-Sensor

Applicant Remedi Co., Ltd.

K number K200284

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MUH 2020-02-20

X-MIND Trium

Applicant De Gotzen S.R.L.

K number K191719

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MUH 2019-12-05

Digital Intraoral Imaging Plate System

Applicant Fsusen Technology Co., Ltd.

K number K192766

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MUH 2019-08-21

ScanX Touch/ScanX Duo Touch

Applicant Air Techniques, Inc.

K number K191623

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MUH 2019-03-01

ODI HD Dental Sensor

Applicant Cnd Global Technologies, Inc.

K number K190234

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MUH 2019-02-12

Cruxcan (CRX-1000)

Applicant Cruxell Corp.

K number K183637

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MUH 2019-01-31

Panoura X-ERA PF/NF/MF

Applicant The Yoshida Dental Mfg. Co., Ltd.

K number K182198

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MUH 2018-11-21

DENTIOIII series (DENTIOIII, DENTIOIII-S)

Applicant Hdx Will Corp.

K number K181297

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MUH 2018-07-20

Aurora

Applicant Sodium Systems, LLC

K number K181636

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MUH 2018-06-20

Televere Digital Dental Imaging System

Applicant Televere Systems, Inc.

K number K181358

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MUH 2017-12-19

FS Ergo

Applicant Palodex Group OY

K number K173646

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MUH 2017-12-18

DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)

Applicant Kavo Dental Technologies, LLC

K number K172918

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MUH 2017-10-26

Cocoon Portable Handheld X-Ray System

Applicant Dexcowin Co., Ltd.

K number K173046

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MUH 2017-07-06

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)

Applicant Villa Sistemi Medicali S.P.A.

K number K162190

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MUH 2017-05-01

ScanX Intraoral View

Applicant Duerr Dental AG

K number K170733

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MUH 2017-04-04

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight

Applicant VATECH Co., Ltd.

K number K170731

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MUH 2017-03-20

Bel-Cypher Pro

Applicant Takara Belmont Corporation

K number K163175

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MUH 2017-03-09

JAZZ SOLO Sensor

Applicant Jazz Imaging, LLC

K number K163224

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MUH 2017-02-28

Apex Dental Sensors

Applicant Masterlink, LLC

K number K163282

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MUH 2016-11-04

I View and Imagen Sensor

Applicant Trident S.R.L

K number K162619

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MUH 2016-11-04

SuniIQ Digital Radiography System

Applicant Suni Medical Imaging, Inc.

K number K162585

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MUH 2016-11-03

FONA Pan/Ceph

Applicant Fona S.R.L

K number K161131

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MUH 2016-04-15

RIOScan (RPS500)

Applicant Ray Co., Ltd.

K number K160788

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MUH 2016-03-10

ReadeR, VieweR, QuickScan PSP

Applicant Trident S.R.L

K number K160386

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MUH 2016-02-10

TIO-H DIGITAL RADIOGRAPHY SENSOR

Applicant Denttio, Inc.

K number K153144

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MUH 2013-11-06

PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

Applicant Genoray Co., Ltd.

K number K130419

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MUH 2013-11-01

RAYSCAN A-EXPERT

Applicant Ray Co., Ltd.

K number K131693

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MUH 2013-09-06

FIRECR DENTALIMAGING SYSTEM

Applicant 3Disc Americas

K number K131442

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MUH 2013-07-18

PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM

Applicant Genoray Co., Ltd.

K number K130088

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MUH 2013-07-15

PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

Applicant VATECH Co., Ltd.

K number K130585

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MUH 2013-03-15

RAYSCAN A-EXPERT

Applicant Ray Co., Ltd.

K number K122918

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MUH 2013-03-08

IMAGE WORKS PANOURA

Applicant Mic International

K number K122806

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MUH 2013-01-24

POINT 500 HD POINT500C HD

Applicant Pointnix Co., Ltd.

K number K121800

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MUH 2013-01-07

VANTAGE MODEL V5000, V5100, V5000C, V5100C

Applicant Midmark Corp.

K number K122643

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MUH 2012-12-27

EVA SELECT DIGITAL DENTAL IMAGING SYSTEM

Applicant Afp Imaging Corp.

K number K123419

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MUH 2012-09-04

PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

Applicant VATECH Co., Ltd.

K number K122155

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MUH 2012-07-10

VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

Applicant Genoray Co., Ltd.

K number K120263

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MUH 2012-06-22

CS 8100 CS 8100 ACCESS

Applicant Trophy

K number K120975

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MUH 2012-05-07

APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM

Applicant Apixia, Inc.

K number K120106

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MUH 2012-03-27

PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

Applicant VATECH Co., Ltd.

K number K113672

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MUH 2012-03-06

VIVI ERGON-X HF

Applicant Vivi S.R.L.

K number K120318

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MUH 2012-01-17

HYPERION

Applicant Cefla S.C. Cefla Dental Group

K number K113497

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MUH 2012-01-05

DIGITAL X-RAY IMAGING SYSTEM

Applicant Rf Co., Ltd.

K number K111103

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MUH 2011-12-15

INTRAORAL BELSENSOR GOLD

Applicant Takara Belmont USA, Inc.

K number K102456

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MUH 2011-11-22

CLEARVISION

Applicant Midmark Corp.

K number K112380

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MUH 2011-09-23

CS 7600

Applicant Carestream Health, Inc.

K number K111649

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MUH 2011-09-19

EDLEN IMAGING - GEMINI DUSB

Applicant Edlen Imaging, LLC

K number K103290

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MUH 2011-07-22

ROTOGRAPH EVO 3D

Applicant Villa Sistemi Medicali S.P.A.

K number K111152

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MUH 2011-07-13

PANOURA 18S

Applicant The Yoshida Dental Mfg. Co., Ltd.

K number K111231

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MUH 2011-04-20

COMPUTED DENTAL RADIOGRAPHY

Applicant Schick Technologies, Inc.

K number K110768

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MUH 2011-03-17

ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY

Applicant Panoramic Corp.

K number K110371

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MUH 2011-03-17

PLANMECA PROMAX 3D MID

Applicant Planmeca Oy

K number K103689

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MUH 2011-02-17

BEL-CYPHER N

Applicant Takara Belmont Corporation

K number K110160

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MUH 2010-10-22

DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM

Applicant VATECH Co., Ltd.

K number K102124

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MUH 2010-10-21

WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS

Applicant Cefla Dental Group

K number K100960

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MUH 2010-10-06

ORTHOPANTOMOGRAPH OP300

Applicant Instrumentarium Dental, Palodex Group OY

K number K093683

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MUH 2010-09-16

MYRAY HYPERION

Applicant Cefla Dental Group

K number K101661

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MUH 2010-07-20

SOPIX 2

Applicant Sopro

K number K092329

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MUH 2010-05-12

PLANMECA PROMAX 3D MAX

Applicant Planmeca Oy

K number K093590

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MUH 2010-04-26

KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM

Applicant Trophy

K number K093478

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MUH 2010-04-26

VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

Applicant Genoray Co., Ltd.

K number K092171

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