Alltech Medical Systems America, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Alltech Medical Systems America, Inc. makes
Alltech Medical Systems America, Inc. manufactures 1.5T MRI systems, including the Comfort EC710 and ECHOSTAR series (SPICA and standard models), designed for diagnostic imaging in clinical settings.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
Comfort EC710 Ref K163192
Regimes: 510(k) Registry: 510(k)Echostar Comfort 1.5T Mri Ref K141945
Regimes: CE MDD 510(k) Registry: EUDAMED510(k)Echostar Spica 1.5T Mr System Ref K113511
Regimes: CE MDD 510(k) Registry: 510(k)Alltech Echostar 1.5 T Mr System Ref K082100
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 828375696
FDA recalls
FDA recall records list 1 recall initiated by Alltech Medical Systems America, Inc., initiated on 2015-01-09. 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.
2015
- 9 Jan 2015 Z-1061-2015 Class I Terminated The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Frequently asked questions
How many devices does Alltech Medical Systems America, Inc. have in the registry?
The registry currently lists 6 devices for Alltech Medical Systems America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alltech Medical Systems America, Inc.'s devices?
Among its 6 most recently registered devices, Alltech Medical Systems America, Inc. has devices listed in EUDAMED (1 device), FDA 510(k) (4 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Alltech Medical Systems America, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Alltech Medical Systems America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Alltech Medical Systems America, Inc.?
FDA recall records list 1 recall initiated by Alltech Medical Systems America, Inc., the most recent initiated on 9 Jan 2015. 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 Alltech Medical Systems America, Inc. in the registry?
The most recently registered devices listed for Alltech Medical Systems America, Inc. include NA Comfort EC710, NA Echostar Comfort, Comfort EC710 and ECHOSTAR COMFORT 1.5T MRI.