Aperio Technologies
Country not established
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Aperio Technologies makes
Aperio Technologies manufactures the SCANSCOPE XT System, a digital pathology imaging platform designed for high-resolution scanning and analysis of glass slides in laboratory settings.
The SCANSCOPE XT System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) premarket notification process. The company is based in the United States.
Catalogue
Scanscope Xt System Ref K071671
Regimes: 510(k) Registry: 510(k)Scanscope Xt System Ref K073677
Regimes: 510(k) Registry: 510(k)Scanscope Xt System Ref K080564
Regimes: 510(k) Registry: 510(k)Scanscope Xt System Ref K080254
Regimes: 510(k) Registry: 510(k)Scanscope Xt System Ref K071128
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Aperio Technologies, initiated on 2013-02-22. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 22 Feb 2013 Z-1549-2013 Class II Terminated Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.
Frequently asked questions
How many devices does Aperio Technologies have in the registry?
The registry currently lists 5 devices for Aperio Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aperio Technologies's devices?
Among its 5 most recently registered devices, Aperio Technologies has devices listed in FDA 510(k) (5 devices).
What risk classes do Aperio Technologies's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Aperio Technologies's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Aperio Technologies?
FDA recall records list 1 recall initiated by Aperio Technologies, the most recent initiated on 22 Feb 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Aperio Technologies in the registry?
The most recently registered devices listed for Aperio Technologies include SCANSCOPE XT SYSTEM.