Who else makes this device?

Name: ddR Element
Brand: ddR Element

Ddr Element · System, X-Ray, Stationary → Radiology

7manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

2recalls on this 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 ddR Element
Listed by	Swissray Medical, AG, Switzerland
FDA product code	KPR
Device type	System, X-Ray, Stationary
Device class	Class 2
Regulation	21 CFR 892.1680
Establishment	Repacker / relabeller, Complaint-file establishment
510(k)	K110828
Record published	2024-04-16

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for ddR Element
Catalogue number	Size	Status
ddR Element		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
K110828	2011-08-23
K070678	2007-05-02
K052943	2005-12-15
K973710	1997-12-18

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2016-11-18	Class II	Device Design	Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.	27 devices in US
2016-08-09	Class II	Device Design	Possible injury due to movement of the arm, calibration loss and communication loss.	26 units

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.

Ddr Element