Capsule Tech, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Capsule Tech, Inc. makes
Capsule Tech, Inc. manufactures the DATACAPTOR SYSTEM, a medical device designed for capturing and transmitting internal imaging data during gastrointestinal procedures.
The DATACAPTOR SYSTEM is classified as Class II under FDA regulations and is listed via 510(k) clearance. The company is based in the United States.
Catalogue
Datacaptor System Ref K113835
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Capsule Tech, Inc., the earliest on 2010-08-25 and the most recent on 2012-08-10. By recorded status: 2 terminated. The reasons filed fall into these groups: software or firmware and electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 10 Aug 2012 Z-2377-2012 Class II Terminated Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron
Full distribution text
- 10 Aug 2012 Z-2377-2012 Class II Terminated Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron
2010
- 25 Aug 2010 Z-2403-2011 Unclassified (pre-2012) Terminated Software: Data cached on the Neuron due to server unavailability is not being delivered to the server after server availability is restored. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes. Batteries can discharge completely in a Capsule Neuron" UMPC even though it is connected to power source
Frequently asked questions
How many devices does Capsule Tech, Inc. have in the registry?
The registry currently lists 1 device for Capsule Tech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Capsule Tech, Inc.'s devices?
Among its 1 most recently registered device, Capsule Tech, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Capsule Tech, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Capsule Tech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Capsule Tech, Inc.?
FDA recall records list 2 recalls initiated by Capsule Tech, Inc., the most recent initiated on 10 Aug 2012. 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 Capsule Tech, Inc. in the registry?
The most recently registered devices listed for Capsule Tech, Inc. include DATACAPTOR SYSTEM.