The following data is part of a premarket notification filed by Covidien Llc with the FDA for Illumisite Platform.
| Device ID | K191394 |
| 510k Number | K191394 |
| Device Name: | ILLUMISITE Platform |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Covidien Llc 161 Cheshire Lane N, Suite 100 Plymouth, MN 55441 |
| Contact | Kristi Fox |
| Correspondent | Kristi Fox Covidien Llc 161 Cheshire Lane N, Suite 100 Plymouth, MN 55441 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-24 |
| Decision Date | 2019-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521779990 | K191394 | 000 |
| 10884521723634 | K191394 | 000 |
| 10884521723832 | K191394 | 000 |
| 10884521723825 | K191394 | 000 |
| 10884521723818 | K191394 | 000 |
| 10884521812383 | K191394 | 000 |
| 20884521807980 | K191394 | 000 |
| 10884521812413 | K191394 | 000 |
| 20884521842424 | K191394 | 000 |
| 10884521723771 | K191394 | 000 |
| 10884521723788 | K191394 | 000 |
| 10884521779983 | K191394 | 000 |
| 10884521723993 | K191394 | 000 |
| 10884521723986 | K191394 | 000 |
| 10884521723979 | K191394 | 000 |
| 10884521723962 | K191394 | 000 |
| 10884521723955 | K191394 | 000 |
| 10884521723801 | K191394 | 000 |
| 10884521723795 | K191394 | 000 |
| 10884521837096 | K191394 | 000 |