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

VERITON NM

Spectrum Dynamics Medical SA · 🇨🇭 Switzerland
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
07649991184011
Basic UDI-DI Code
7649991184VERITONLU
Reference
8010184-01
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
Not Intended For Eu Market

Additional Description

The VERITON™ NM (Nuclear Medicine) system is a multi-organ CZT based SPECT camera. The VERITON NM system intend to perform general nuclear medicine imaging procedures for the detection of radioisotope tracer uptake in a patient’s body. The system scanning modes include tomographic, static, gated and dynamic modes using physiological signals. The acquisition types include circular and body contouring scans. VERITON™ NM system includes analysis and display equipment, patient supports, components and accessories. The system may include data and image processing software (provided by third-party vendors) to produce images in a variety of trans-axial and reformatted planes. The images can also be post-processed to obtain additional images, imaging planes, analysis results, and uptake quantitation. The system may be used for patients of all ages.

CND Nomenclature Codes

Code Description
Z11020105 FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION

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