Transducer, Ultrasonic
FDA product code JOP · Class II (moderate risk) · 21 CFR 870.2880 · Cardiovascular
72510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Advanced Technology Laboratories, Inc. 7
- Acuson Computed Sonography 6
- Imex Medical Systems, Inc. 3
- Ge Medical Systems Information Technologies 3
- Interspec, Inc. 3
- Koven Technology, Inc. 3
- Johnson & Johnson Professionals, Inc. 3
- Siemens Medical Solutions USA, Inc. 2
- General Electric Co. 2
- Applied Biometrics, Inc. 2
- Ultramed, Inc. 2
- Millar Instruments, Inc. 2
- Hoffrel Instruments, Inc. 2
- Ausonics Pty , Ltd. 2
- Viasonix , Ltd. 2
- Biosound, Inc. 2
- Echocath, Inc. 2
- Hewlett-Packard Co. 2
- Elscint, Inc. 2
- Sonicaid, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K925078 | SpectradopJOP · Traditional | Bennett and Assoc., Inc. | 07/17/1995SE |
| K934638 | Reusable CW Doppler Probes: Models P8M05S8A, P8M05N5A, & LCW-8JOP · Traditional | Koven Technology, Inc. | 05/13/1994SE |
| K912409 | Model HD-207 Bidirectional Velocity MeterJOP · Traditional | Koven and Assoc., Inc. | 12/23/1991SE |
| K911320 | Extravascular Doppler (Evd) Ultra Blood Flow ProbeJOP · Traditional | Applied Biometrics, Inc. | 12/18/1991SE |
| K910281 | Intravascular Imaging System/ModifiedJOP · Traditional | Intertherapy, Inc. | 05/13/1991SE |
| K905157 | Floscope Vascular Lab.JOP · Traditional | Advance Medical Device, Inc. | 03/15/1991SE |
| K905369 | UST-2266U-5 CW Doppler TransducerJOP · Traditional | Ge Medical Systems Information Technologies | 02/11/1991SE |
| K896264 | Millar Mikro-Tip Doppler CatheterJOP · Traditional | Millar Instruments, Inc. | 01/24/1990SE |
| K890638 | Volume Computation Software PackageJOP · Traditional | Elscint, Inc. | 08/07/1989SE |
| K890636 | Cardiac Computation Software PackageJOP · Traditional | Elscint, Inc. | 08/07/1989SE |
| K892944 | Interspec Transesophageal Probe Model 4515JOP · Traditional | Interspec, Inc. | 07/19/1989SE |
| K881979 | Resubmittal of Mi 1000C MicroimagerJOP · Traditional | Ausonics Pty , Ltd. | 06/12/1989SE |
| K883889 | Transesophageal Echo TransducerJOP · Traditional | General Electric Co. | 11/29/1988SE |
| K873674 | SDU-700 Phased Array Sector and Linear ScannerJOP · Traditional | Shimadzu Corp. | 10/07/1988SE |
| K881723 | Genesis II 7.5MHZ Ultrasound TransducerJOP · Traditional | Biosound, Inc. | 08/12/1988SE |
| K871442 | Biosound Mmi UltrasoundJOP · Traditional | Biosound, Inc. | 05/20/1988SE |
| K873989 | Dopplex Ultrasonic Doppler SystemJOP · Traditional | Ultramed, Inc. | 03/02/1988SE |
| K870857 | Abcom 1 Cardiac Output MonitorJOP · Traditional | Applied Biometrics, Inc. | 11/16/1987SE |
| K870726 | RT5000 Echocardiography #H4100C/CEJOP · Traditional | General Electric Co. | 10/20/1987SE |
| K871727 | Modified Radius - Model Number MM 5000JOP · Traditional | Ultrasonix, Inc. | 09/30/1987SE |
| K871506 | Acuson L538 TransducerJOP · Traditional | Acuson Computed Sonography | 09/28/1987SE |
| K871416 | Auxiliary Continuous Wave Doppler TransducerJOP · Traditional | Acuson Computed Sonography | 09/28/1987SE |
| K870850 | Mod 482JOP · Traditional | Hoffrel Instruments, Inc. | 09/08/1987SE |
| K872074 | 5 MHZ TransducerJOP · Traditional | Sonicaid, Inc. | 08/25/1987SE |
| K871212 | Mascot CW Doppler SystemJOP · Traditional | Imex Medical Systems, Inc. | 08/14/1987SE |
| K870607 | SSD-725 Ultrasound Sector ScannerJOP · Traditional | Ge Medical Systems Information Technologies | 08/10/1987SE |
| K870150 | Continuous Cardiac Output Monitoring SystemJOP · Traditional | Cardio Metrics, Inc. | 08/07/1987SE |
| K870916 | SSD-633 Phased Array Sector/Linear Ultrasound Sys.JOP · Traditional | Ge Medical Systems Information Technologies | 07/21/1987SE |
| K864980 | 3MHZ Annular ArrayJOP · Traditional | Philips Ultrasound, Inc. | 05/11/1987SE |
| K862913 | Cardioscan with Doppler OptionJOP · Traditional | Interspec, Inc. | 11/04/1986SE |
| K861596 | Acuson S519 TransducerJOP · Traditional | Acuson Computed Sonography | 07/30/1986SN |
| K861579 | Acuson L558 TransducerJOP · Traditional | Acuson Computed Sonography | 07/30/1986SN |
| K862159 | Acuson S319 TransducerJOP · Traditional | Acuson Computed Sonography | 07/24/1986SE |
| K861737 | Meridian Imaging SystemJOP · Traditional | Johnson & Johnson Professionals, Inc. | 07/24/1986SN |
| K861866 | Acuson L382 and L312 TransducersJOP · Traditional | Acuson Computed Sonography | 07/18/1986SE |
| K861378 | Ultramed TF 122 Ultrason Vascu Imag & Doppler SystJOP · Traditional | Ultramed, Inc. | 07/07/1986SE |
| K860579 | Cardioscan Doppler OptionJOP · Traditional | Interspec, Inc. | 06/30/1986SE |
| K860652 | Ultrasound Transducer #21230A 7.5MHZ Short FocusJOP · Traditional | Hewlett-Packard Co. | 05/08/1986SE |
| K854996 | Ultrasonic Couplant GelJOP · Traditional | Johnson & Johnson Professionals, Inc. | 04/14/1986SE |
| K853240 | Meridian Ultrasound Imaging SystemJOP · Traditional | Johnson & Johnson Professionals, Inc. | 02/21/1986SE |
| K853138 | Millar Mikro-Tip Doppler CatheterJOP · Traditional | Millar Instruments, Inc. | 10/29/1985SE |
| K850165 | Motor Drive, Mechanical Sector SCANNING-MOD417JOP · Traditional | Hoffrel Instruments, Inc. | 10/23/1985SE |
| K851616 | 3.5. MHZ Probe for Ausonics 150 & 357 Real Time CaJOP · Traditional | Ausonics Pty , Ltd. | 07/29/1985SE |
| K851269 | Doplette 10JOP · Traditional | Imex Medical Systems, Inc. | 07/29/1985SE |
| K850216 | Cardiac Sector Probe 5.0 MHZJOP · Traditional | Siemens Medical Solutions USA, Inc. | 04/10/1985SE |
| K850145 | Cardiac Sector Probe 3.5. MHZJOP · Traditional | Siemens Medical Solutions USA, Inc. | 04/10/1985SE |
| K843058 | Q-DopJOP · Traditional | Quinton, Inc. | 04/10/1985SE |
| K842539 | Diagnostic Ultrasound 105 & 110JOP · Traditional | Diagnostic Ultrasound Corp. | 04/10/1985SE |
| K843953 | Scanheads Access 10 10PV B10JOP · Traditional | Advanced Technology Laboratories, Inc. | 03/12/1985SE |
| K843620 | Scanheads-Access 10PV, BiostaticJOP · Traditional | Advanced Technology Laboratories, Inc. | 03/12/1985SE |
| K843911 | Access CJOP · Traditional | Advanced Technology Laboratories, Inc. | 03/05/1985SE |
| K843165 | Ultrasound 72X & Annular Array Scan-JOP · Traditional | Advanced Technology Laboratories, Inc. | 12/20/1984SE |
| K843131 | Access & 72X Ultrasound Scanhead UM4JOP · Traditional | Advanced Technology Laboratories, Inc. | 12/20/1984SE |
| K843130 | Scanhead 2.25MHZ Added to Ultramark 4JOP · Traditional | Advanced Technology Laboratories, Inc. | 12/06/1984SE |
| K843129 | Scanhead 2.25MHZ Added to Ultramark 8JOP · Traditional | Advanced Technology Laboratories, Inc. | 12/06/1984SE |
| K842460 | VF-PD-120JOP · Traditional | Valpey-Fisher Corp. | 10/19/1984SE |
| K843262 | Transesophageal Echocardiography UltrasoJOP · Traditional | Hewlett-Packard Co. | 08/23/1984SE |
| K840542 | Mini-Doppler ES-100JOP · Traditional | Hayashi Denki Co., Ltd. | 07/16/1984SE |
| K834525 | Angioscan Flo Mad Spectrum AnalyzerJOP · Traditional | Unigon Industries, Inc. | 05/23/1984SE |
| K832369 | Vascular Recorder #301JOP · Traditional | Imex Medical Systems, Inc. | 03/12/1984SE |
| K833902 | VasoscanJOP · Traditional | Sonicaid, Inc. | 01/27/1984SE |
| K810414 | Usci Doppler Catheter SystemJOP · Traditional | C.R. Bard, Inc. | 08/12/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2167-2014 Class II | Esaote PA230E Transducer A portable and cart base ultrasound system for general and…Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode… | Biosound Esaote, Inc. | 06/26/2014Terminated |