The following data is part of a premarket notification filed by Imd Systems, Inc. with the FDA for Dyna Vue 3-d Imaging Product.
| Device ID | K974755 |
| 510k Number | K974755 |
| Device Name: | DYNA VUE 3-D IMAGING PRODUCT |
| Classification | System, Image Processing, Radiological |
| Applicant | IMD SYSTEMS, INC. 74 SPRING RD. Amherst, NH 03031 |
| Contact | Kenneth M Nicoll |
| Correspondent | Kenneth M Nicoll IMD SYSTEMS, INC. 74 SPRING RD. Amherst, NH 03031 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-19 |
| Decision Date | 1998-03-04 |
| Summary: | summary |