Ausonics Opus 1 System, Annular Array Option
FDA 510(k) K920307 · Ausonics Pty , Ltd.
510(k) numberK920307
Submission
- Device name
- Ausonics Opus 1 System, Annular Array Option
- Applicant
- Ausonics Pty , Ltd.
Washington, DC, US - Received
- January 23, 1992
- Decision date
- May 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Ausonics Opus 1 System, Annular Array Option cleared by the FDA?
Ausonics Opus 1 System, Annular Array Option (K920307) received a 510(k) decision of Substantially Equivalent on May 19, 1992, 117 days after the submission was received.
What is the product code of K920307?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.