Medical device licence · 67049 · Class 2
THINPREP IMAGING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 11, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 67049
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 11, 2005
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- THINPREP IMAGING SYSTEM - BLUING SOLUTION
- THINPREP IMAGING SYSTEM - EA SOLUTION
- THINPREP IMAGING SYSTEM - IMAGE PROCESSOR CONTROLLER
- THINPREP IMAGING SYSTEM - IMAGING STATION
- THINPREP IMAGING SYSTEM - INSTALLATION KIT
- THINPREP IMAGING SYSTEM - NUCLEAR STAIN SOLUTION
- THINPREP IMAGING SYSTEM - ORANGE G SOLUTION
- THINPREP IMAGING SYSTEM - REMOTE REVIEW SITE KIT
- THINPREP IMAGING SYSTEM - REVIEW SCOPE
- THINPREP IMAGING SYSTEM - REVIEW SCOPE SWITCHBOXES
- THINPREP IMAGING SYSTEM - RINSE SOLUTION
- THINPREP IMAGING SYSTEM - SLIDE ACCESSION ID UTILITY SOFTWARE
- THINPREP IMAGING SYSTEM - SLIDE CASSETTES
- THINPREP IMAGING SYSTEM - STAIN SET
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 “thinprep”. A notice may cover another product or only some lots: read it to see what it covers.
- ThinPrep Processors (2015-06-24)July 8, 2015 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.