The following data is part of a premarket notification filed by Dynamic Imaging Inc. with the FDA for Integradweb Mpr/mip.
| Device ID | K042313 |
| 510k Number | K042313 |
| Device Name: | INTEGRADWEB MPR/MIP |
| Classification | System, Image Processing, Radiological |
| Applicant | DYNAMIC IMAGING INC. 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Contact | Carl Alletto |
| 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 | 2004-08-26 |
| Decision Date | 2004-09-09 |
| Summary: | summary |