DRF 4343-LT System DI

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref 8784000001Model DRF 4343-LT SystemRef 8793000003

Identity

Trade Name: DRF 4343-LT System DI EUDAMED
Device Name: DRF 4343-LT System EUDAMED
Model / Reference: DRF 4343-LT System EUDAMED
8784000001 EUDAMED
8793000003 EUDAMED

Device Class: Class IIb EUDAMED
Medical Purpose: DRF 4343-LT SYSTEM is an X-ray digital image acquisition and processing system adopting a dynamic X-ray flat panel detector, which allows to perform static and dynamic radiological diagnostic exams in real time. DRF 4343-LT SYSTEM can provide images and dynamic digital sequences of adult and pediatric subjects within diagnostic radiology applications, without limitations on the target patient population. DRF 4343-LT SYSTEM is intended for use by healthcare professionals such as radiographers/radiology technicians working in general radiology diagnostic rooms or emergency rooms. The use of DRF 4343-LT SYSTEM for mammography and dental radiology is excluded. EUDAMED

Sterile

EUDAMED

DRF 4343-LT System DI by Villa Sistemi Medicali S.p.a. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K080859	Class IIb	Active
EUDAMED	European Union	CE/MDR	805773712FT258A5	Class IIb	Active

Is this your device? Claim it to add documentation and request validation.