Unit, X-ray, Extraoral With Timer

Product Code: EHD

Dental Dental Diagnostic X-Ray Equipment

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 EHD

5257Unit, X-ray, Extraoral With TimerExtraoral Source X-ray System.

Total Product Life Cycle (TPLC) Devices

5257Unit, X-ray, Extraoral With TimerExtraoral Source X-ray System.

FDA Consensus Standards

Unit, X-Ray, Extraoral With Timer [37034]21 CFR §872.1800 🔎
Unit, X-Ray, Extraoral With Timer [29008]21 CFR §872.1800 🔎
Unit, X-Ray, Extraoral With Timer [37035]21 CFR §872.1800 🔎

Pre-market Notifications for EHD

K223058EzRay Air 2 Wall (Model: VEX-S350W)Vatech Co., Ltd
K222569Ai Ray Dental X-Ray DeviceGuilin Woodpecker Medical Instrument Co., Ltd.
K222274FONA XDCFONA S.r.l
K221286CLAROXVSI Co., Ltd.
K221233DT-703ECOTRON Co., Ltd
K220574HYBRID S70Digimed Co., LTD.
K220579Hybrid C70Digimed Co., Ltd
K211014PortraySurround Medical Systems
K201800Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)NANORAY Co., Ltd.
K200182EzRay Air Portable (Model: VEX-P300)Vatech Co., Ltd
K192700XcamHDX WILL Corp.
K190935EZER, Portable X-ray SystemLivermoretech Inc.
K190357Star-X, Intraoral X-ray SystemHDX WILL Corp.
K182206RiX70 DCTrident S.r.l
K181891Portable X-ray System (Model: MiniX-V, Mini X-S)Digimed Co., LTD.

Global Unique Device Identification Database

00868923000275Unit, X-Ray, Extraoral With Timer
00868923000268Unit, X-Ray, Extraoral With Timer
00868923000251Unit, X-Ray, Extraoral With Timer
00868923000244Unit, X-Ray, Extraoral With Timer
00868923000237Unit, X-Ray, Extraoral With Timer
00868923000220Unit, X-Ray, Extraoral With Timer
00868923000213Unit, X-Ray, Extraoral With Timer
00868923000206Unit, X-Ray, Extraoral With Timer
00862309000378Unit, X-Ray, Extraoral With Timer
00862309000361Unit, X-Ray, Extraoral With Timer
00862309000354Unit, X-Ray, Extraoral With Timer
00862309000347Unit, X-Ray, Extraoral With Timer
00862309000330Unit, X-Ray, Extraoral With Timer
00862309000316Unit, X-Ray, Extraoral With Timer
00862309000309Unit, X-Ray, Extraoral With Timer

Maude Adverse Events

NOMAD PROAIRBEX2020-03-11
NOMAD PRO2ARIBEX2020-02-20
GX-770GENDEX DENTAL SYSTEMS2019-10-23
GX-770GENDEX DENTAL SYSTEMS2019-10-04
NOMAD PRO2AIRBEX2019-09-16
NOMAD DENTAL 60KVAIRBEX2019-09-09
NOMAD PROAIRBEX2019-08-28
NOMAD DENTAL 60KVARIBEX2019-06-24
GENDEX EXPERT DCGENDEX DENTAL SYSTEMS2019-05-23
GX-770GENDEX DENTAL SYSTEMS2019-05-10
2019-03-21
2019-03-21
ORTHORALIX 9200GENDEX DENTAL SYSTEMS2019-03-18
NOMAD PRO2AIRBEX2019-03-18
NOMAD PROAIRBEX2019-03-18
2019-03-01
2019-03-01
GENDEX GX-770DENTAL IMAGING TECHNOLOGIES CORPORATION2019-02-26
2019-02-21
NOMAD PROARIBEX2019-01-31
NOMAD PROARIBEX2019-01-16
NOMAD PRO2ARIBEX2019-01-14
2018-12-11
2018-11-19
2018-10-22
2018-10-08
2018-10-05
2018-09-27
NOMAD PRO 2ARIBEX2018-09-12
PANORAMIC X-RAY MODEL PC-1000YOUNG INNOVATIONS2018-08-28
NOMAD PRO 2ARIBEX2018-08-28
NOMAD PROARIBEX2018-08-17
2018-08-15
2018-08-15
NOMAD PRO 2ARIBEX2018-07-20
NOMAD PRO HANDHELD X-RAY SYSTEMARIBEX2018-06-22
PANORAMIC X-RAY MODEL PC-1000YOUNG INNOVATIONS2018-06-13
NOMAD PRO 2ARIBEX2018-04-23
PANORAMIC X-RAY MODEL PC 1000YOUNG INNOVATIONS2018-04-12
NOMAD PRO 2ARIBEX2018-03-23
NOMAD PROARIBEX2018-03-01
765 DCGENDEX DENTAL SYSTEMS2018-02-14
JB-70MIDMARK CORPORATION2018-01-11
NOMAD PRO 2ARIBEX2017-11-29
NOMAD PRO 2ARIBEX2017-11-27
NOMAD PROARIBEX2017-11-08
NOMAD PROARIBEX2017-11-07
NOMAD PRO 2ARIBEX2017-11-02
NOMAD PROARIBEX2017-11-01
NOMAD PRO 2ARIBEX2017-10-20
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