Cine Recall Function/Opus 1 Real Time Scanner
FDA 510(k) K915715 · Ausonics Pty , Ltd.
510(k) numberK915715
Submission
- Device name
- Cine Recall Function/Opus 1 Real Time Scanner
- Applicant
- Ausonics Pty , Ltd.
Washington, DC, US - Received
- October 8, 1991
- Decision date
- July 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K883925 | UroimagerIYO · Traditional | 12/15/1988SE |
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| K883372 | Alpha MC-9S Mobil C-Arm Image Intensifier UnitJAA · Traditional | 11/25/1988SE |
Questions and answers
When was Cine Recall Function/Opus 1 Real Time Scanner cleared by the FDA?
Cine Recall Function/Opus 1 Real Time Scanner (K915715) received a 510(k) decision of Substantially Equivalent on July 2, 1992, 268 days after the submission was received.
What is the product code of K915715?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.