The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Mammography X-ray Equipment Models Mgf101 And Mgf110, Alpha Iii, Alpha St, Alpha Rt And Alpha Iq.
| Device ID | K981641 |
| 510k Number | K981641 |
| Device Name: | MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ |
| Classification | System, X-ray, Mammographic |
| Applicant | INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
| Contact | Max Lindert |
| Correspondent | Max Lindert INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-08 |
| Decision Date | 1998-07-17 |