Eu Mdr Eu Md Class 2a On The Market 🇮🇱 Israel

D-SPECT CARDIO

Spectrum Dynamics Medical ltd · 🇮🇱 Israel
Devices (same UDI-DI)
2
Certificates
0
Countries
8
Notified Bodies
0

Basic Information

Primary DI
07290108670073
Basic UDI-DI Code
729010867DSPECTFJ
Reference
8010121-01
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

The D-SPECT® system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the patient’s body and to produce cross-sectional images through computer reconstruction of the data. The D-SPECT system is intended for use by appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of cardiac diseases. The system output can be used for planning, guiding and monitoring therapy. The D-SPECT system consists of integrated signal analysis and display equipment or may use the D-SPECT Processing and Reviewing Workstation for image processing.

CND Nomenclature Codes

Code Description
Z11020104 FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇬🇷 Greece 🇮🇹 Italy 🇸🇪 Sweden

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