The following data is part of a premarket notification filed by Dome Imaging Systems, Inc. with the FDA for Dome Cx Digital Flat-panel Display System, Model C5i.
| Device ID | K040443 |
| 510k Number | K040443 |
| Device Name: | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I |
| Classification | System, Image Processing, Radiological |
| Applicant | DOME IMAGING SYSTEMS, INC. 400 FIFTH AVENUE Waltham, MA 02451 |
| Contact | Susan Hamann |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-02-20 |
| Decision Date | 2004-06-16 |
| Summary: | summary |