Bioimaging and radiotherapy instrumentsDigital bioimaging management instrumentsDigital computed radiography (cr) systems

Digital computed radiography (cr) systems - hardware accessories

EMDN code Z11060280

6 manufacturers, 28 models including 28 on the market, 5 countries

On the market in Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 6

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Agfa FDA	Belgium	CR HD5.0 FLFS CASSETTE CR: HD5.0, HM5.0, MD4.0R(cassettes)3 refs CR MD1.0 CASSETTE ADAPTER CR MD1.0 GENERAL SET CR MD1.0 Set3 refs CR MD4.0 GENERAL SET CR Set Mx.093/42 CR MD4.0 GENERAL SET HR CR Set Mx.093/42 8 others CR MD4.0 GENERAL SET SR CR Set Mx.093/42 CR MD4.0R FLFS SET CR: HD5.0, HM5.0, MD4.0R93/42 CR MD4.0R GENERAL (SR) SET CR: HD5.0, HM5.0, MD4.0R4 refs93/42 CR MD4.0T FLFS SET CR Set Mx.0T93/42 CR MD4.0T GENERAL SET CR Set Mx.0T5 refs93/42 CR MM3.0 MAMMO SET CR Set Mx.02 refs93/42 CR MM3.0T MAMMO SET CR Set Mx.0T2 refs93/42 ID-tablet	I, IIa MDR, 93/42	Website EUDAMED record Report an error
Konica Minolta FDA EU representative : Konica Minolta Business Solutions Europe GmbH (Netherlands)	Japan	CP1M2002 refs93/42 FP-1S8 refs93/42 RC-3003 refs RP-4L, RP-4T22 refs93/42 RP4S1108 refs93/42 1 other RP6M11012 refs93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany)	Japan	FUJI IP CASSETTE CC3 refs FUJI IP CASSETTE DM2 refs FUJI IP CASSETTE LC3 refs FUJI IP CASSETTE PC3 refs FUJI IP CASSETTE Type CH2 refs	I MDR	EUDAMED record Report an error
Carestream Dental FDA EU representative : TROPHY (France)	United States	CSD Smart Plate3 refs IMAGING PLATE #03 refs	IIa MDR	EUDAMED record Report an error
Cruxell FDA EU representative : Obelis s.a. (Belgium)	South Korea	CRUXCAN CRX-1000	IIa MDR	Website info@cruxell.com EUDAMED record Report an error
General Medical Merate FDA	Italy	OPERA D4000RAD2 refs	IIb MDR	Website info@gmmspa.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 6

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Carestream Health, Inc. Present in Europe in other categories	United States	LANEX Regular Screens Select Cassette with LANEX Medium Screens Select Cassette with LANEX Regular Screens Imaging Plate LANEX Fine Screens X-OMATIC Regular Screens	registered
Flow X Ray Corporation	United States	Wolf X-Ray	registered
3D DENTAL DESIGNS AND DEVELOPMENT, LLC	–	Visionary by 3D Dental	registered
DARBY DENTAL SUPPLY, LLC	–	Darby Dental Supply, LLC	registered
Dimedi Co., Ltd. Present in Europe in other categories	South Korea	–	registered
Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd	India	–	registered

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