The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Ausonics-alpha I Diagnostic X-ray Mammography Unit.
| Device ID | K850173 |
| 510k Number | K850173 |
| Device Name: | AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT |
| Classification | System, X-ray, Mammographic |
| Applicant | AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | Willian C Nealon |
| Correspondent | Willian C Nealon AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield, CT 06078 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-16 |
| Decision Date | 1985-04-16 |