Who else makes this device?

Name: DX-D 600
Brand: DX-D 600

DX-D 600 · System, X-Ray, Stationary → Radiology

7manufacturers in China registered for this device type

4catalogue numbers in this listing

3recalls 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 DX-D 600
Listed by	Agfa Healthcare Inc., Canada
FDA product code	KPR
Device type	System, X-Ray, Stationary
Device class	Class 2
Regulation	21 CFR 892.1680
Establishment	Specification developer, Manufacturer
510(k)	K112670
Record published	2016-09-01
Record revised	2019-06-14 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for DX-D 600
Catalogue number	Size	Status
5430/110		In distribution
5430/100		In distribution
5430/050		In distribution
5430/120		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

Recalls Naming This Product

4 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of DX-D 600
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Agfa Healthcare N.V.	510(k) number	2018-12-04	Class II	Software design	After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released,	10	2020-04-24
Agfa Healthcare N.V.	510(k) number	2018-08-15	Class II	Component design/selection	A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or exc	108	2020-06-23
Agfa Healthcare Inc.	510(k) number	2016-05-02	Class II	Labeling design	One of the dent markers from the DX-D600 dropped down from the overhead rail.	81 units	2017-04-10
Agfa Healthcare Inc.	510(k) number	2014-07-02	Class II	Device Design	Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.	17 units	2015-06-04

Recalls

The FDA has not published a severity grade for these. 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	Closed
2005-11-18	Not classified	Other	Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.	1059 units	2012-01-12

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.

DX-D 600