The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Alpha Ii Diagnostic X-ray.
| Device ID | K864958 |
| 510k Number | K864958 |
| Device Name: | ALPHA II DIAGNOSTIC X-RAY |
| Classification | System, X-ray, Mammographic |
| Applicant | AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | William C Nealon |
| Correspondent | William 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 | 1986-12-18 |
| Decision Date | 1987-01-30 |