The following data is part of a premarket notification filed by Medicsight Plc with the FDA for Coloncad Api 3.1.
| Device ID | K083423 |
| 510k Number | K083423 |
| Device Name: | COLONCAD API 3.1 |
| Classification | Colon Computed Tomography System, Computer Aided Detection |
| Applicant | MEDICSIGHT PLC 66 HAMMERSMITH ROAD London, GB W148ud |
| Contact | Amarjit Gill |
| Correspondent | Amarjit Gill MEDICSIGHT PLC 66 HAMMERSMITH ROAD London, GB W148ud |
| Product Code | NWE |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-19 |
| Decision Date | 2011-05-17 |
| Summary: | summary |