The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Cine Recall Function/opus 1 Real Time Scanner.
| Device ID | K915715 |
| 510k Number | K915715 |
| Device Name: | CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | AUSONICS PTY LTD. 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Contact | Richard S Morey |
| Correspondent | Richard S Morey AUSONICS PTY LTD. 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-08 |
| Decision Date | 1992-07-02 |