Alltech Medical Systems America Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 4
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1061-2015 | Class I | Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body. | January 9, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K163192 | Comfort EC710 | April 10, 2017 |
| K141945 | ECHOSTAR COMFORT 1.5T MRI | February 3, 2015 |
| K113511 | ECHOSTAR SPICA 1.5T MR SYSTEM | May 2, 2012 |
| K082100 | ALLTECH ECHOSTAR 1.5 T MR SYSTEM | August 6, 2008 |