The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Iva (mxa Ii Software Option).
| Device ID | K060111 |
| 510k Number | K060111 |
| Device Name: | IVA (MXA II SOFTWARE OPTION) |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Jeanette Schier-pugsley |
| Correspondent | Jeanette Schier-pugsley HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-17 |
| Decision Date | 2006-04-24 |
| Summary: | summary |