The following data is part of a premarket notification filed by Planar Systems, Inc. with the FDA for Planar Dome Ex Line Model Dome E2c.
| Device ID | K061018 |
| 510k Number | K061018 |
| Device Name: | PLANAR DOME EX LINE MODEL DOME E2C |
| Classification | System, Image Processing, Radiological |
| Applicant | PLANAR SYSTEMS, INC. 1195 NW COMPTON DRIVE Beaverton, OR 97006 |
| Contact | Craig Harshman |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-04-28 |
| Summary: | summary |