The following data is part of a premarket notification filed by Superdimension, Ltd. with the FDA for Inreach System.
| Device ID | K080271 |
| 510k Number | K080271 |
| Device Name: | INREACH SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SUPERDIMENSION, LTD. 161 CHESHIRE LANE NORTH, SUITE 100 Minneapolis, MN 55441 -5433 |
| Contact | Jonathan Kovach |
| Correspondent | Jonathan Kovach SUPERDIMENSION, LTD. 161 CHESHIRE LANE NORTH, SUITE 100 Minneapolis, MN 55441 -5433 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-01 |
| Decision Date | 2008-03-31 |
| Summary: | summary |