The following data is part of a premarket notification filed by Superdimension, Ltd. with the FDA for Inreach Planning Laptop.
| Device ID | K082386 |
| 510k Number | K082386 |
| Device Name: | INREACH PLANNING LAPTOP |
| Classification | System, Image Processing, Radiological |
| Applicant | SUPERDIMENSION, LTD. 161 CHESHIRE LANE NORTH, SUITE 100 Minneapolis, MN 55441 -5433 |
| Contact | Margaret Depuydt |
| Correspondent | Margaret Depuydt SUPERDIMENSION, LTD. 161 CHESHIRE LANE NORTH, SUITE 100 Minneapolis, MN 55441 -5433 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-19 |
| Decision Date | 2008-09-16 |
| Summary: | summary |