KARL 100 2.0 SYSTEM

Primary DI

08056351100137

Basic UDI-DI Code

8056351100000KARL2.0SYSPL

Reference

135000059

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Essential system performance: protect operators and patients from radiation in the best possible way – carried out by the KARL100 2.0 and dose measurement through the NUVIA ISOMED 2010 dose calibrator. Typically the KARl100 2.0 SYSTEM fractionates 18F radiopharmaceuticals ± 10% of the prescribed dose and ± 2% of the measured dose, compared in any case to the certified reference value of the dose calibrator. In any case, the KARl100 2.0 displays the measurement data without any modification of the values ​​received from the certified dose calibrator inserted in the system. Ability to verify each single dose administered before injection for validation and periodic checks.

The transportable automatic fractionation system (Karl 100 2.0 System) is a medical system for the safe storage and protection of operators of the FDG radiopharmaceutical ([18F]-fluorodeoxyglucose) and, associated with a dose calibrator, manages the measurement of the fractionation by placing the radiopharmaceutical with the necessary level of activity in a syringe.

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