Applied Spectral Imaging , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140957 | GENASIS HIPATH IHC FAMILY | January 15, 2015 |
| K122554 | GENASIS SCANVIEW SYSTEM | February 7, 2013 |
| K110345 | SCANVIEW SYSTEM | October 19, 2011 |
| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | November 23, 2010 |
| K071398 | SCANVIEW, MODEL SC-300 | October 4, 2007 |
| K050236 | FISHVIEW | June 27, 2005 |
| K012103 | BANDVIEW SYSTEM | September 14, 2001 |
| K973950 | RETINAL CUBE | December 12, 1997 |