Who else makes this device?

Name: Box for ExamVue DR(outside 265mmx185mmx150mm)
Brand: Box for ExamVue DR(outside 265mmx185mmx150mm)

Radiology › DiagnosticSystem, X-Ray, Stationary

Box for ExamVue DR(Outside 265mmx185mmx150mm)

The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR…

Registry build 21.09.26

The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.

7manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (3), Beijing (2), Jiangsu (1).

Chinese manufacturers registered for FDA product code KPR
Manufacturer	City	Province	Registered as	Device types
GE Hangwei Medical Systems Co., Ltd.	Beijing	Beijing	Specification developer	22
GE Healthcare (China) Co., Ltd.	Beijing	Beijing	Specification developer	22
Shanghai United Imaging Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	12
Siemens Shanghai, Medical Equipment Ltd.	Shanghai	Shanghai	Contract manufacturer	10
Carestream Health, Inc., Global R&D Center	Shanghai	Shanghai	Specification developer	8
Philips Healthcare (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	5
Orich Medical Equipment (Tianjin) Co., Ltd.	Tianjin	Tianjin	Manufacturer	5

Record

Regulatory record for Box for ExamVue DR(outside 265mmx185mmx150mm)
Listed by	JPI Healthcare Co., Ltd., South Korea
FDA product code	KPR
Device type	System, X-Ray, Stationary
Device class	Class 2
Regulation	21 CFR 892.1680
Establishment	Complaint-file establishment, Manufacturer, Exporter
510(k)	K142930
Record published	2020-04-10

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Box for ExamVue DR(outside 265mmx185mmx150mm)
Catalogue number	Size	Status
ExamVue DR		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Drgem	Drgem Corporation	171
Q-RAD System	Carestream Health, Inc.	159
DRX – Ascend System	Carestream Health, Inc.	121
FDR Clinica	Drgem Corporation	41
RADspeed Pro	Shimadzu Corp.	31
FDR Visionary Suite	Shimadzu Corp.	17
Exsys DEXi	Drtech Corporation	15
Del Medical, Inc.	DEL Medical, Inc.	15
GXR-Es,ecs Diagnostic X-ray System	Drgem Corporation	14
X-CEL X-RAY Corporation	Arquilla, Inc.	14
DRX-Evolution Plus System	Carestream Health, Inc.	12
Carestream DRX-Evolution	Carestream Health, Inc.	10

Showing 12 of 138. All products under System, X-Ray, Stationary

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K260482	2026-06-15
K213057	2022-02-18
K142930	2015-04-17
K101779	2011-05-16

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.