Who else makes this device?

Name: Unit, X-Ray, Extraoral With Timer
Brand: Unit, X-Ray, Extraoral With Timer

Dental › DiagnosticUnit, X-Ray, Extraoral With Timer

Unit, X-Ray, Extraoral With Timer

- Extraoral source x-ray system Battery Input: 22.2V, 1A Output Rating: 210W kVp: 70kV mA: 3mA Sec: 0.02 - 0.5sec

Registry build 21.09.26

8manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Guangxi (2), Guangdong (2), Zhejiang (2).

Chinese manufacturers registered for FDA product code EHD
Manufacturer	City	Province	Registered as	Device types
Guilin Woodpecker Medical Instrument Co., Ltd.	Guilin	Guangxi	Manufacturer	25
Changzhou Sifary Medical Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	14
Guangzhou Ajax Medical Equipment Co Ltd	Guangzhou	Guangdong	Manufacturer	13
Guilin Refine Medical Instrument Co., Ltd.	Guilin	Guangxi	Contract manufacturer	7
iRay Imaging Technology (Haining) Limited	Haining	Zhejiang	Contract manufacturer	6
Orich Medical Equipment (Tianjin) Co., Ltd.	Tianjin	Tianjin	Manufacturer	5
Ningbo Runyes Medical Instrument Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	4
Shenzhen Xpectvision Technology Co., Ltd.	Shenzhen	Guangdong	Repacker / relabeller	4

Record

Regulatory record for Unit, X-Ray, Extraoral With Timer
Listed by	Ecotron Co., Ltd., South Korea
FDA product code	EHD
Device type	Unit, X-Ray, Extraoral With Timer
Device class	Class 2
Regulation	21 CFR 872.1800
Establishment	Manufacturer
510(k)	K221233
Record published	2022-07-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Storage	Storage environment humidity 10 to 75 % RH; Storage environment temperature -10 to 60 °C; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 40 °C
Sizes	Width 165 mm; length 259 mm; height 277 mm; weight 1.6 to 1.86 kg

Catalogue Numbers

Catalogue numbers for Unit, X-Ray, Extraoral With Timer
Catalogue number	Size	Status
DT-703	Width 165 mm	In distribution
ProX Go	Width 165 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Midmark	Midmark Corporation	148
Midmark Preva IntraOral Dental X-ray System	Midmark Corporation	136
Schick AE	Sirona Dental, Inc.	53
Midmark Preva 2.0 IntraOral Dental X-ray System	Midmark Corporation	46
Xios AE	Sirona Dental, Inc.	38
X-Mind unity	DE Götzen SRL	26
Midmark Vetpro IntraOral Dental X-ray System	Midmark Corporation	26
x-mind dc	DE Götzen SRL	17
Owandy-RX DC	Owandy Radiology	16
Orthophos XG	Sirona Dental Systems Gmbh	10
Schick Elite	Sirona Dental, Inc.	10
Phot-X IIs Model 505	Takara Belmont Corporation	10

Showing 12 of 171. All products under Unit, X-Ray, Extraoral With Timer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K221233	2022-06-27

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.