JOP · Transducer, Ultrasonic
Cardiovascular · 21 CFR 870.2880 · Class 2
Overview
| Product Code | JOP |
|---|---|
| Device Name | Transducer, Ultrasonic |
| Regulation | 21 CFR 870.2880 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 72)
Showing 20 most recent of 72 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242662 | Falcon/Xpress (Falcon/Xpress) | Viasonix , Ltd. | Dec 18, 2024 | SESE |
| K233976 | VasoGuard (V10, V8, V6, V4, V2) | Corvascular Diagnostics, LLC | Jul 19, 2024 | SESE |
| K153762 | Smartdop XT6 | Koven Technology, Inc. | May 25, 2016 | SESE |
| K131623 | SMARTDOP XT | Koven Technology, Inc. | Jan 17, 2014 | SESE |
| K131860 | VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING | Us Vascular, LLC | Sep 27, 2013 | SESE |
| K111416 | FALCON | Viasonix , Ltd. | Jul 15, 2011 | SESE |
| K071730 | STUDIODOP VICORDER | Skidmore Medical, Limited | Dec 20, 2007 | SESE |
| K010482 | ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 | Echocath, Inc. | Mar 20, 2001 | SESE |
| K002766 | NICOLET VASOGUARD | Nicolet Biomedical | Nov 30, 2000 | SESE |
| K990642 | ECHOFLOW DOPPLER BLOOD VELOCITY METER | Echocath, Inc. | Sep 16, 1999 | SESE |
| K925078 | SPECTRADOP | Bennett and Assoc., Inc. | Jul 17, 1995 | SESE |
| K934638 | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 | Koven Technology, Inc. | May 13, 1994 | SESE |
| K912409 | MODEL HD-207 BIDIRECTIONAL VELOCITY METER | Koven and Assoc., Inc. | Dec 23, 1991 | SESE |
| K911320 | EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE | Applied Biometrics, Inc. | Dec 18, 1991 | SESE |
| K910281 | INTRAVASCULAR IMAGING SYSTEM/MODIFIED | Intertherapy, Inc. | May 13, 1991 | SESE |
| K905157 | FLOSCOPE VASCULAR LAB. | Advance Medical Device, Inc. | Mar 15, 1991 | SESE |
| K905369 | UST-2266U-5 CW DOPPLER TRANSDUCER | Ge Medical Systems Information Technologies | Feb 11, 1991 | SESE |
| K896264 | MILLAR MIKRO-TIP DOPPLER CATHETER | Millar Instruments, Inc. | Jan 24, 1990 | SESE |
| K890638 | VOLUME COMPUTATION SOFTWARE PACKAGE | Elscint, Inc. | Aug 7, 1989 | SESE |
| K890636 | CARDIAC COMPUTATION SOFTWARE PACKAGE | Elscint, Inc. | Aug 7, 1989 | SESE |
Top Applicants
- Advanced Technology Laboratories, Inc. — 7 clearances
- Acuson Computed Sonography — 6 clearances
- Ge Medical Systems Information Technologies — 3 clearances
- Imex Medical Systems, Inc. — 3 clearances
- Interspec, Inc. — 3 clearances
