System, X-ray, Extraoral Source, Digital

Product Code: MUH

Dental Dental Diagnostic X-Ray Equipment

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31]

Code of Federal Regulations: 872.1800


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as MUH

5258System, X-ray, Extraoral Source, DigitalExtraoral Source X-ray System.

Total Product Life Cycle (TPLC) Devices

5258System, X-ray, Extraoral Source, DigitalExtraoral Source X-ray System.

FDA Consensus Standards

System, X-Ray, Extraoral Source, Digital [37034]21 CFR §872.1800 🔎
System, X-Ray, Extraoral Source, Digital [29008]21 CFR §872.1800 🔎
System, X-Ray, Extraoral Source, Digital [37035]21 CFR §872.1800 🔎

Pre-market Notifications for MUH

K221955Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20RealCloud Imaging Inc. Dba RealCloud Imaging
K221008HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)Shanghai Handy Medical Equipment Co., Ltd
K220556OpenSensorX SeriesDentiMax, Inc
K220422Dental Sensors NanoPix1, NanoPix2IRay Technology Taicang Ltd.
K220423PAPAYA & PAPAYA PlusGENORAY Co., Ltd.
K220277Digital Intraoral X-ray SensorShenzhen Xpectvision Technology Co.,Ltd.
K214091Dental Image Plate Scanner, Model DFC-4T-SMARTHefei DentaFilm Medical Equipment Co., Ltd
K213637JAZZ Solo SensorJazz Imaging LLC Dba JAZZ Imaging
K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D And Stellaris 3D CephFONA S.r.l
K212279Digital Intraoral X-ray Imaging SystemIRay Technology Taicang Ltd.
K212103StarX-1, StarX-2, StarX PRO-1 And StarX PRO-2FONA S.r.l
K212080Imaging Plate Scanner, I-ScanGuilin Woodpecker Medical Instrument Co., Ltd.
K211688DC-Air And Athlos-1 And Athlos-AirAthlos Oy
K211317CRUXVIEWCRUXELL Corp.
K210312PlutoX Digital Intraoral X-Ray Imaging SystemIRay Technology Taicang Ltd.

Global Unique Device Identification Database

10366975002577System,X-Ray,Extraoral Source,Digital
10366975002560System,X-Ray,Extraoral Source,Digital
10366975002553System,X-Ray,Extraoral Source,Digital
00862973000353System,X-Ray,Extraoral Source,Digital
00862973000346System,X-Ray,Extraoral Source,Digital
00862309000392System, X-Ray, Extraoral Source, Digital
00862309000385System, X-Ray, Extraoral Source, Digital
00858475006085System,X-Ray,Extraoral Source,Digital
00858475006078System,X-Ray,Extraoral Source,Digital
00858475006054System,X-Ray,Extraoral Source,Digital
00858475006047System,X-Ray,Extraoral Source,Digital
00858475006030System,X-Ray,Extraoral Source,Digital
00858475006023System,X-Ray,Extraoral Source,Digital
00858475006016System,X-Ray,Extraoral Source,Digital
00851067007057System,X-Ray,Extraoral Source,Digital

Maude Adverse Events

CONE BEAM 3D IMAGEUNKNOWN2019-08-13
2019-04-24
2019-03-27
2019-02-21
2019-02-14
2019-01-29
2018-12-21
2018-11-19
2018-10-17
2018-09-19
2018-09-13
KODAK 8000 PANORAMIC SYSTEMCARESTREAM DENTAL LLC2018-09-11
SCANX IO ILEAIR TECHNIQUES INC.2018-08-13
SCANX IOAIR TECHNIQUES INC.2018-08-13
PANORAMIC CCD ENCOMPASSYOUNG INNOVATIONS2018-06-13
SCANX CLASSIC ILEAIR TECHNIQUES INC.2018-05-30
GXS-700GENDEX2017-06-29
GXDP-300PALODEX GROUP OY2017-06-02
GXDP-300PALODEX GROUP OY2017-06-02
KODAK SENSOR 6100CARESTREAM HEALTH, INC.2017-01-31
PLANMECA PROONEPLANMECA OY2016-04-01
CS8100CARESTREAM HEALTH, INC.2015-11-25
DENTAL X RAY (DIGITAL I AM TOLD)2015-08-13
PROVECTA S-PANVATECH CO, LTD2015-01-09
SCANXAIR TECHNIQUES, INC.2014-09-09
SUNISUNIMEDICAL IMAGING, INC.2014-08-27
SUNIRAY DENTAL DIGITAL SENSOR SYSTEMSUNI MEDICAL IMAGING, INC.2014-08-27
PROGENY VANTAGEMIDMARK CORPORATION2014-08-22
SUNI RAY DENTAL DIGITAL SENSOR SYSTEMSUNI MEDICAL IMAGING, INC.2014-08-18
PROGENY VANTAGEMIDMARK CORPORATION2014-05-08
PROGENY VANTAGEMIDMARK CORPORATION2013-07-18
I-CATIMAGING SCIENCES INTERNATIONAL, LLC2012-07-16
I-CATIMAGING SCIENCES INTERNATIONAL, LLC2012-07-02
I-CATIMAGING SCIENCES INTERNATIONAL, LLC2012-07-02
I-CATIMAGING SCIENCES INTERNATIONAL, LLC2012-07-02
GXDP-700PALODEX GROUP OY2012-06-05
PROGENY PREVAMIDMARK CORP2010-08-13
PROGENY PREVAMIDMARK CORPORATION2010-06-11
PROGENY PREVAMIDMARK CORP2010-05-24
PROGENY PREVAMIDMARK CORP2010-05-04
PROGENY PREVAMIDMARK CORPORATION2010-05-04
PROGENY PREVAMIDMARK CORPORATION2010-04-07
CB 500IMAGING SCIENCE INTERNATIONAL, LLC2010-04-01
PROGENY JB-70MIDMARK CORPORATION2010-01-22
PROGENY PREVAMIDMARK CORPORATION2010-01-07
PROGENY PREVAMIDMARK CORPORATION2009-12-17
PROGENY PREVAMIDMARK CORPORATION2009-12-17
PROGENY PREVAMIDMARK CORP.2009-12-08
PROGENY PREVAMIDMARK CORP.2009-11-24
PROGENY PREVAMIDMARK CORPORATION2009-11-12
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