3.5. MHZ Probe for Ausonics 150 & 357 Real Time Ca
FDA 510(k) K851616 · Ausonics Pty , Ltd.
510(k) numberK851616
Submission
- Device name
- 3.5. MHZ Probe for Ausonics 150 & 357 Real Time Ca
- Applicant
- Ausonics Pty , Ltd.
Suffield, CT, US - Received
- April 18, 1985
- Decision date
- July 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOP – Transducer, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2880
- Specialty
- Cardiovascular
Other 510(k)s with product code JOP
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|---|---|---|---|
| K242662 | Falcon/Xpress (Falcon/Xpress)JOP · Traditional | Viasonix , Ltd. | 12/18/2024SE |
| K233976 | VasoGuard (V10, V8, V6, V4, V2)JOP · Traditional | Corvascular Diagnostics, LLC | 07/19/2024SE |
| K153762 | Smartdop XT6JOP · Traditional | Koven Technology, Inc. | 05/25/2016SE |
| K131623 | Smartdop XTJOP · Traditional | Koven Technology, Inc. | 01/17/2014SE |
| K131860 | Vasculab VL4000 Photoplethysmograph with Pulse Volume RecordingJOP · Traditional | Us Vascular, LLC | 09/27/2013SE |
| K111416 | FalconJOP · Traditional | Viasonix , Ltd. | 07/15/2011SE |
| K071730 | Studiodop VicorderJOP · Abbreviated | Skidmore Medical, Limited | 12/20/2007SE |
| K010482 | Echoflow Portable Doppler Blood Flow Measurement System; Model PEF-1JOP · Special | Echocath, Inc. | 03/20/2001SE |
| K002766 | Nicolet VasoguardJOP · Abbreviated | Nicolet Biomedical | 11/30/2000SE |
| K990642 | Echoflow Doppler Blood Velocity MeterJOP · Traditional | Echocath, Inc. | 09/16/1999SE |
More from Echocath, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933916 | Ausonics Opus 2 Realtime Ultrasound ScannerIYN · Traditional | 10/03/1994SE |
| K915715 | Cine Recall Function/Opus 1 Real Time ScannerIYO · Traditional | 07/02/1992SE |
| K920307 | Ausonics Opus 1 System, Annular Array OptionITX · Traditional | 05/19/1992SE |
| 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 |
| K896714 | Ausonics 5000IYO · Traditional | 06/11/1990SE |
| 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 |
Questions and answers
When was 3.5. MHZ Probe for Ausonics 150 & 357 Real Time Ca cleared by the FDA?
3.5. MHZ Probe for Ausonics 150 & 357 Real Time Ca (K851616) received a 510(k) decision of Substantially Equivalent on July 29, 1985, 102 days after the submission was received.
What is the product code of K851616?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.