The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Alpha Iii Plus And Model P2500f/101 W/optional.
| Device ID | K896596 |
| 510k Number | K896596 |
| Device Name: | ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL |
| Classification | System, X-ray, Mammographic |
| Applicant | INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Contact | Gerry Buss |
| Correspondent | Gerry Buss 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 | 1989-11-21 |
| Decision Date | 1991-05-30 |