The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Diamond (mammographic X-ray System).
| Device ID | K000976 |
| 510k Number | K000976 |
| Device Name: | DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) |
| Classification | System, X-ray, Mammographic |
| Applicant | INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Contact | Max Lindert |
| Correspondent | Max Lindert INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-06-01 |