The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Delta 32 And Delta 32 Tact.
| Device ID | K002472 |
| 510k Number | K002472 |
| Device Name: | DELTA 32 AND DELTA 32 TACT |
| Classification | System, X-ray, Mammographic |
| Applicant | INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Contact | Tommi Jokiniemi |
| Correspondent | Tommi Jokiniemi 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 | 2000-08-11 |
| Decision Date | 2000-11-29 |