Product code JOP
- Device name
- Transducer, Ultrasonic
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2880
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242662 | Falcon/Xpress (Falcon/Xpress) | Viasonix , Ltd. | 2024-12-18 |
| K233976 | VasoGuard (V10, V8, V6, V4, V2) | Corvascular Diagnostics, LLC | 2024-07-19 |
| K153762 | Smartdop XT6 | Koven Technology, Inc. | 2016-05-25 |
| K131623 | SMARTDOP XT | Koven Technology, Inc. | 2014-01-17 |
| K131860 | VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING | Us Vascular, LLC | 2013-09-27 |
| K111416 | FALCON | Viasonix , Ltd. | 2011-07-15 |
| K071730 | STUDIODOP VICORDER | Skidmore Medical, Limited | 2007-12-20 |
| K010482 | ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 | Echocath, Inc. | 2001-03-20 |
| K002766 | NICOLET VASOGUARD | Nicolet Biomedical | 2000-11-30 |
| K990642 | ECHOFLOW DOPPLER BLOOD VELOCITY METER | Echocath, Inc. | 1999-09-16 |
| K925078 | SPECTRADOP | Bennett and Assoc., Inc. | 1995-07-17 |
| K934638 | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 | Koven Technology, Inc. | 1994-05-13 |
| K912409 | MODEL HD-207 BIDIRECTIONAL VELOCITY METER | Koven and Assoc., Inc. | 1991-12-23 |
| K911320 | EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE | Applied Biometrics, Inc. | 1991-12-18 |
| K910281 | INTRAVASCULAR IMAGING SYSTEM/MODIFIED | Intertherapy, Inc. | 1991-05-13 |
| K905157 | FLOSCOPE VASCULAR LAB. | Advance Medical Device, Inc. | 1991-03-15 |
| K905369 | UST-2266U-5 CW DOPPLER TRANSDUCER | Ge Medical Systems Information Technologies | 1991-02-11 |
| K896264 | MILLAR MIKRO-TIP DOPPLER CATHETER | Millar Instruments, Inc. | 1990-01-24 |
| K890638 | VOLUME COMPUTATION SOFTWARE PACKAGE | Elscint, Inc. | 1989-08-07 |
| K890636 | CARDIAC COMPUTATION SOFTWARE PACKAGE | Elscint, Inc. | 1989-08-07 |
| K892944 | INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 | Interspec, Inc. | 1989-07-19 |
| K881979 | RESUBMITTAL OF MI 1000C MICROIMAGER | Ausonics Pty , Ltd. | 1989-06-12 |
| K883889 | TRANSESOPHAGEAL ECHO TRANSDUCER | General Electric Co. | 1988-11-29 |
| K873674 | SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER | Shimadzu Corp. | 1988-10-07 |
| K881723 | GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER | Biosound, Inc. | 1988-08-12 |
| K871442 | BIOSOUND MMI ULTRASOUND | Biosound, Inc. | 1988-05-20 |
| K873989 | DOPPLEX ULTRASONIC DOPPLER SYSTEM | Ultramed, Inc. | 1988-03-02 |
| K870857 | ABCOM 1 CARDIAC OUTPUT MONITOR | Applied Biometrics, Inc. | 1987-11-16 |
| K870726 | RT5000 ECHOCARDIOGRAPHY #H4100C/CE | General Electric Co. | 1987-10-20 |
| K871727 | MODIFIED RADIUS - MODEL NUMBER MM 5000 | Ultrasonix, Inc. | 1987-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888937029536 | CooperSurgical® | Coopersurgical, Inc. | 2026-04-10 |
| G677H1V08 | VasoGuard | CorVascular | 2026-04-08 |
| G677H1V10 | VasoGuard | CorVascular | 2026-04-08 |
| G677H2V02 | VasoGuard | CorVascular | 2026-04-08 |
| G677H2V04 | VasoGuard | CorVascular | 2026-04-08 |
| G677VG0201 | VasoGuard | CorVascular | 2026-04-08 |
| G677VG0401 | VasoGuard | CorVascular | 2026-04-08 |
| G677VG0601 | VasoGuard | CorVascular | 2026-04-08 |
| G677VG0801 | VasoGuard | CorVascular | 2026-04-08 |
| G677VG1001 | VasoGuard | CorVascular | 2026-04-08 |
| G677H1V06 | VasoGuard | CorVascular | 2026-04-08 |
| 00888937027839 | CooperSurgical® | Coopersurgical, Inc. | 2026-04-01 |
| 00888937027815 | CooperSurgical® | Coopersurgical, Inc. | 2026-04-01 |
| 00888937027822 | CooperSurgical® | Coopersurgical, Inc. | 2025-09-25 |
| 00894912002272 | Adaptor | KOVEN TECHNOLOGY, INC. | 2016-10-18 |
| 00894912002210 | Doppler adaptor | KOVEN TECHNOLOGY, INC. | 2016-10-18 |
| 00894912002227 | Adaptor | KOVEN TECHNOLOGY, INC. | 2016-10-18 |
| 00894912002234 | Adaptor | KOVEN TECHNOLOGY, INC. | 2016-10-18 |
| 00894912002241 | Adaptor | KOVEN TECHNOLOGY, INC. | 2016-10-18 |
| 00894912002258 | Adaptor | KOVEN TECHNOLOGY, INC. | 2016-10-18 |
| 00894912002265 | Adaptor | KOVEN TECHNOLOGY, INC. | 2016-10-18 |
| 00894912002906 | Temp probe | KOVEN TECHNOLOGY, INC. | 2016-02-25 |
| 00894912002852 | Smartdop XT | KOVEN TECHNOLOGY, INC. | 2016-02-25 |
| 00894912002845 | PG-01 | KOVEN TECHNOLOGY, INC. | 2016-02-25 |
| 00894912002838 | Temp Probe | KOVEN TECHNOLOGY, INC. | 2016-02-25 |
| 00894912002128 | HD-307 | KOVEN TECHNOLOGY, INC. | 2016-02-24 |
| 00894912002111 | HD-307 | KOVEN TECHNOLOGY, INC. | 2016-02-24 |
| 00894912002104 | HD-307 | KOVEN TECHNOLOGY, INC. | 2016-02-24 |
| 00894912002043 | BiDop 3 | KOVEN TECHNOLOGY, INC. | 2016-02-24 |
| 00894912002029 | ES100X MiniDop | KOVEN TECHNOLOGY, INC. | 2016-02-24 |