Medical device licence · 97311 · Class 2
RADSPEED PRO
Yes: licensed in Canada
Licence status Issued (active); first licensed July 15, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97311
- Licence holder
- Shimadzu CorporationNakagyo-Ku, 26, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 15, 2016
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CEILING TYPE X-RAY TUBE SUPPORT CH-200
- COLLIMATOR TYPE RC-300
- RADSPEED PRO
- RADSPEED PRO X-RAY COLLIMATOR
- RADSPEED PRO X-RAY HIGH VOLTAGE GENERATOR
- RADSPEED PRO X-RAY TUBE
- RADSPEED PRO X-RAY TUBE SUPPORT
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “radspeed”. A notice may cover another product or only some lots: read it to see what it covers.
- RADspeed Pro X-Ray and CH-200, CH-200M Ceiling Tube SupportsNovember 13, 2025 · Radiology · Performance · Type II
- Radspeed Pro X-Ray and CH-200 Ceiling Tube SupportsMay 19, 2023 · Radiology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.