Falcon/Xpress (Falcon/Xpress)
FDA 510(k) K242662 · Viasonix , Ltd.
510(k) numberK242662
Submission
- Device name
- Falcon/Xpress (Falcon/Xpress)
- Applicant
- Viasonix , Ltd.
Ra'Anana, IL - Received
- September 4, 2024
- Decision date
- December 18, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K925078 | SpectradopJOP · Traditional | Bennett and Assoc., Inc. | 07/17/1995SE |
More from Bennett and Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryIYN · Traditional | 01/25/2021SE |
| K192607 | LiteWalkIRP · Traditional | 12/19/2019SE |
| K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAXIYN · Special | 05/16/2019SE |
| K170859 | Dolphin/IQ and Dolphin/4DIYN · Traditional | 11/14/2017SE |
| K111416 | FalconJOP · Traditional | 07/15/2011SE |
Questions and answers
When was Falcon/Xpress (Falcon/Xpress) cleared by the FDA?
Falcon/Xpress (Falcon/Xpress) (K242662) received a 510(k) decision of Substantially Equivalent on December 18, 2024, 105 days after the submission was received.
What is the product code of K242662?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.