Medical device licence · 99352 · Class 3
RHYTHMIA HDX MAPPING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 27, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99352
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 27, 2017
- Devices covered
- 52
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BSC 6.1 INSTALLATION USB
- EGM OUT TO SIGNAL STATION CABLE - IBI
- EGM OUT TO SIGNAL STATION CABLE - STOCKERT
- FORCE COMPUTATION MODULE 3.0 USB
- FORCE COMPUTATION SW MODULE V2.1
- OPAL HDX 6.5 INSTALLATION USB
- OPAL HDX 7.0 SOFTWARE INSTALLATION USB
- OPAL HDX 72 INTRACARDIAC OUT CABLE
- OPAL HDX ABLATION CONNECTION BOX (IBI/AMPERE)
- OPAL HDX BREAKOUT BOX
- OPAL HDX BREAKOUT BOX CABLE
- OPAL HDX CARDIOLAB DIRECT CONNECT ECG
- OPAL HDX CARDIOLAB DIRECT CONNECT IC
- OPAL HDX CLEARSIGN DIRECT CONNECT ECG
- OPAL HDX CLEARSIGN DIRECT CONNECT IC A/B
- OPAL HDX CLEARSIGN DIRECT CONNECT IC ORION
- OPAL HDX ECG OUT BOX (AAMI)
- OPAL HDX ECG OUT BOX (IEC)
- OPAL HDX LOCALIZATION GENERATOR
- OPAL HDX LOCALIZATION GENERATOR CABLE
- OPAL HDX MAPPING SYSTEM - LOCATION REFERENCE PATCH KIT
- OPAL HDX MAPPING SYSTEM EVALUATION ROW
- OPAL HDX MAPPING SYSTEM INSTALL BUNDLE ROW
- OPAL HDX MAPPING SYSTEM SIGNAL STATION
- OPAL HDX MAPPING SYSTEM WORKSTATION PC
- OPAL HDX PATCH CABLE
- OPAL HDX STIMULATOR JUMPER CABLE
- RHYTHMIA HDX 72 INTRACARDIAC OUT CABLE
- RHYTHMIA HDX AAMI ECG IN CABLE
- RHYTHMIA HDX AAMI ECG OUT BOX
- RHYTHMIA HDX ABLATION CONNECTION BOX
- RHYTHMIA HDX BREAKOUT BOX
- RHYTHMIA HDX BREAKOUT BOX CABLE
- RHYTHMIA HDX CARDIOLAB DIRECT CONNECT ECG
- RHYTHMIA HDX CARDIOLAB DIRECT CONNECT IC
- RHYTHMIA HDX CLEARSIGN DIRECT CONNECT ECG
- RHYTHMIA HDX CLEARSIGN DIRECT CONNECT IC A/B
- RHYTHMIA HDX CLEARSIGN DIRECT CONNECT ORION
- RHYTHMIA HDX FOOT SWITCH
- RHYTHMIA HDX IEC ECG IN CABLE
- RHYTHMIA HDX IEC ECG OUT BOX
- RHYTHMIA HDX INSTALL BUNDLE ROW MAPPING SYSTEM
- RHYTHMIA HDX LOCALIZATION GENERATOR
- RHYTHMIA HDX LOCALIZATION GENERATOR CABLE
- RHYTHMIA HDX MAPPING SYSTEM - LOCATION REFERENCE PATCH KIT
- RHYTHMIA HDX PATCH CABLE
- RHYTHMIA HDX SIGNAL STATION
- RHYTHMIA HDX STIMULATOR JUMPER CABLE
- RHYTHMIA HDX V6.0 INSTALL
- RHYTHMIA HDX V6.0.1 INSTALL
- RHYTHMIA HDX WORKSTATION PC
- RYTHMIA HDX MAPPING SYSTEM SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.