Ausonics Opus 2 Realtime Ultrasound Scanner
FDA 510(k) K933916 · Ausonics Pty , Ltd.
510(k) numberK933916
Submission
- Device name
- Ausonics Opus 2 Realtime Ultrasound Scanner
- Applicant
- Ausonics Pty , Ltd.
Washington, DC, US - Received
- August 11, 1993
- Decision date
- October 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IYN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional | Sonoscape Medical Corp. | 08/24/2026SE |
| K261668 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary care… | 08/07/2026SE |
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/30/2026SE |
| K261288 | Handheld Ultrasound ScannerIYN · Traditional | Imgfax Co., Ltd. | 07/30/2026SE |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
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| K905488 | Doppler Upgrade for Ausonics Opus 1 Real Time ScanLMB · Traditional | 12/18/1991SE |
| K902728 | 7.5 MHZ Bi Plane Rectal Probe (P/N: 041-815)ITX · Traditional | 02/13/1991SE |
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| K881979 | Resubmittal of Mi 1000C MicroimagerJOP · Traditional | 06/12/1989SE |
| K884299 | Apa-C Catalog Number A-8001-CIYO · Traditional | 01/10/1989SE |
| K883925 | UroimagerIYO · Traditional | 12/15/1988SE |
| K883079 | WWDS-005 Human Rectal ProbeIYO · Traditional | 12/14/1988SE |
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Questions and answers
When was Ausonics Opus 2 Realtime Ultrasound Scanner cleared by the FDA?
Ausonics Opus 2 Realtime Ultrasound Scanner (K933916) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 418 days after the submission was received.
What is the product code of K933916?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.