Eu Mdr Eu Md Class 2a Not Intended For Eu Market 🇨🇭 Switzerland

D-SPECT VISTA

Spectrum Dynamics Medical SA · 🇨🇭 Switzerland
Devices (same UDI-DI)
2
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
07649991184097
Basic UDI-DI Code
7649991184D-SPECTYM
Reference
8010267-01
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
Not Intended For Eu Market

Additional Description

The D-SPECT® VISTA 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® VISTA 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® VISTA 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

Related Devices

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Similar Devices

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).

View all