FDA Product Code
FDA Product Code JOP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2880
510(k) Clearances — 72 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242662 | Falcon/Xpress (Falcon/Xpress) | Viasonix , Ltd. | 2024-12-18 | Traditional | PDF ↗ |
| K233976 | VasoGuard (V10, V8, V6, V4, V2) | Corvascular Diagnostics, LLC | 2024-07-19 | Traditional | PDF ↗ |
| K153762 | Smartdop XT6 | Koven Technology, Inc. | 2016-05-25 | Traditional | PDF ↗ |
| K131623 | SMARTDOP XT | Koven Technology, Inc. | 2014-01-17 | Traditional | PDF ↗ |
| K131860 | VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING | Us Vascular, LLC | 2013-09-27 | Traditional | PDF ↗ |
| K111416 | FALCON | Viasonix , Ltd. | 2011-07-15 | Traditional | PDF ↗ |
| K071730 | STUDIODOP VICORDER | Skidmore Medical, Limited | 2007-12-20 | Abbreviated | PDF ↗ |
| K010482 | ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 | Echocath, Inc. | 2001-03-20 | Special | PDF ↗ |
| K002766 | NICOLET VASOGUARD | Nicolet Biomedical | 2000-11-30 | Abbreviated | PDF ↗ |
| K990642 | ECHOFLOW DOPPLER BLOOD VELOCITY METER | Echocath, Inc. | 1999-09-16 | Traditional | PDF ↗ |
| K925078 | SPECTRADOP | Bennett and Assoc., Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K934638 | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 | Koven Technology, Inc. | 1994-05-13 | Traditional | PDF ↗ |
| K912409 | MODEL HD-207 BIDIRECTIONAL VELOCITY METER | Koven and Assoc., Inc. | 1991-12-23 | Traditional | PDF ↗ |
| K911320 | EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE | Applied Biometrics, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K910281 | INTRAVASCULAR IMAGING SYSTEM/MODIFIED | Intertherapy, Inc. | 1991-05-13 | Traditional | PDF ↗ |
| K905157 | FLOSCOPE VASCULAR LAB. | Advance Medical Device, Inc. | 1991-03-15 | Traditional | PDF ↗ |
| K905369 | UST-2266U-5 CW DOPPLER TRANSDUCER | Ge Medical Systems Information Technologies | 1991-02-11 | Traditional | PDF ↗ |
| K896264 | MILLAR MIKRO-TIP DOPPLER CATHETER | Millar Instruments, Inc. | 1990-01-24 | Traditional | PDF ↗ |
| K890636 | CARDIAC COMPUTATION SOFTWARE PACKAGE | Elscint, Inc. | 1989-08-07 | Traditional | PDF ↗ |
| K890638 | VOLUME COMPUTATION SOFTWARE PACKAGE | Elscint, Inc. | 1989-08-07 | Traditional | PDF ↗ |
| K892944 | INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 | Interspec, Inc. | 1989-07-19 | Traditional | PDF ↗ |
| K881979 | RESUBMITTAL OF MI 1000C MICROIMAGER | Ausonics Pty , Ltd. | 1989-06-12 | Traditional | PDF ↗ |
| K883889 | TRANSESOPHAGEAL ECHO TRANSDUCER | General Electric Co. | 1988-11-29 | Traditional | PDF ↗ |
| K873674 | SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER | Shimadzu Corp. | 1988-10-07 | Traditional | PDF ↗ |
| K881723 | GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER | Biosound, Inc. | 1988-08-12 | Traditional | PDF ↗ |
| K871442 | BIOSOUND MMI ULTRASOUND | Biosound, Inc. | 1988-05-20 | Traditional | PDF ↗ |
| K873989 | DOPPLEX ULTRASONIC DOPPLER SYSTEM | Ultramed, Inc. | 1988-03-02 | Traditional | PDF ↗ |
| K870857 | ABCOM 1 CARDIAC OUTPUT MONITOR | Applied Biometrics, Inc. | 1987-11-16 | Traditional | PDF ↗ |
| K870726 | RT5000 ECHOCARDIOGRAPHY #H4100C/CE | General Electric Co. | 1987-10-20 | Traditional | PDF ↗ |
| K871727 | MODIFIED RADIUS - MODEL NUMBER MM 5000 | Ultrasonix, Inc. | 1987-09-30 | Traditional | PDF ↗ |
| K871416 | AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER | Acuson Computed Sonography | 1987-09-28 | Traditional | PDF ↗ |
| K871506 | ACUSON L538 TRANSDUCER | Acuson Computed Sonography | 1987-09-28 | Traditional | PDF ↗ |
| K870850 | MOD 482 | Hoffrel Instruments, Inc. | 1987-09-08 | Traditional | PDF ↗ |
| K872074 | 5 MHZ TRANSDUCER | Sonicaid, Inc. | 1987-08-25 | Traditional | PDF ↗ |
| K871212 | MASCOT CW DOPPLER SYSTEM | Imex Medical Systems, Inc. | 1987-08-14 | Traditional | PDF ↗ |
| K870607 | SSD-725 ULTRASOUND SECTOR SCANNER | Ge Medical Systems Information Technologies | 1987-08-10 | Traditional | PDF ↗ |
| K870150 | CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM | Cardio Metrics, Inc. | 1987-08-07 | Traditional | PDF ↗ |
| K870916 | SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS. | Ge Medical Systems Information Technologies | 1987-07-21 | Traditional | PDF ↗ |
| K864980 | 3MHZ ANNULAR ARRAY | Philips Ultrasound, Inc. | 1987-05-11 | Traditional | PDF ↗ |
| K862913 | CARDIOSCAN WITH DOPPLER OPTION | Interspec, Inc. | 1986-11-04 | Traditional | PDF ↗ |
| K861579 | ACUSON L558 TRANSDUCER | Acuson Computed Sonography | 1986-07-30 | Traditional | PDF ↗ |
| K861596 | ACUSON S519 TRANSDUCER | Acuson Computed Sonography | 1986-07-30 | Traditional | PDF ↗ |
| K861737 | MERIDIAN IMAGING SYSTEM | Johnson & Johnson Professionals, Inc. | 1986-07-24 | Traditional | PDF ↗ |
| K862159 | ACUSON S319 TRANSDUCER | Acuson Computed Sonography | 1986-07-24 | Traditional | PDF ↗ |
| K861866 | ACUSON L382 AND L312 TRANSDUCERS | Acuson Computed Sonography | 1986-07-18 | Traditional | PDF ↗ |
| K861378 | ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST | Ultramed, Inc. | 1986-07-07 | Traditional | PDF ↗ |
| K860579 | CARDIOSCAN DOPPLER OPTION | Interspec, Inc. | 1986-06-30 | Traditional | PDF ↗ |
| K860652 | ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS | Hewlett-Packard Co. | 1986-05-08 | Traditional | PDF ↗ |
| K854996 | ULTRASONIC COUPLANT GEL | Johnson & Johnson Professionals, Inc. | 1986-04-14 | Traditional | PDF ↗ |
| K853240 | MERIDIAN ULTRASOUND IMAGING SYSTEM | Johnson & Johnson Professionals, Inc. | 1986-02-21 | Traditional | PDF ↗ |
| K853138 | MILLAR MIKRO-TIP DOPPLER CATHETER | Millar Instruments, Inc. | 1985-10-29 | Traditional | PDF ↗ |
| K850165 | MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 | Hoffrel Instruments, Inc. | 1985-10-23 | Traditional | PDF ↗ |
| K851269 | DOPLETTE 10 | Imex Medical Systems, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K851616 | 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA | Ausonics Pty , Ltd. | 1985-07-29 | Traditional | PDF ↗ |
| K842539 | DIAGNOSTIC ULTRASOUND 105 & 110 | Diagnostic Ultrasound Corp. | 1985-04-10 | Traditional | PDF ↗ |
| K850216 | CARDIAC SECTOR PROBE 5.0 MHZ | Siemens Medical Solutions USA, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K843058 | Q-DOP | Quinton, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K850145 | CARDIAC SECTOR PROBE 3.5. MHZ | Siemens Medical Solutions USA, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K843620 | SCANHEADS-ACCESS 10PV, BIOSTATIC | Advanced Technology Laboratories, Inc. | 1985-03-12 | Traditional | PDF ↗ |
| K843953 | SCANHEADS ACCESS 10 10PV B10 | Advanced Technology Laboratories, Inc. | 1985-03-12 | Traditional | PDF ↗ |
| K843911 | ACCESS C | Advanced Technology Laboratories, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K843165 | ULTRASOUND 72X & ANNULAR ARRAY SCAN- | Advanced Technology Laboratories, Inc. | 1984-12-20 | Traditional | PDF ↗ |
| K843131 | ACCESS & 72X ULTRASOUND SCANHEAD UM4 | Advanced Technology Laboratories, Inc. | 1984-12-20 | Traditional | PDF ↗ |
| K843129 | SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8 | Advanced Technology Laboratories, Inc. | 1984-12-06 | Traditional | PDF ↗ |
| K843130 | SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4 | Advanced Technology Laboratories, Inc. | 1984-12-06 | Traditional | PDF ↗ |
| K842460 | VF-PD-120 | Valpey-Fisher Corp. | 1984-10-19 | Traditional | PDF ↗ |
| K843262 | TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO | Hewlett-Packard Co. | 1984-08-23 | Traditional | PDF ↗ |
| K840542 | MINI-DOPPLER ES-100 | Hayashi Denki Co., Ltd. | 1984-07-16 | Traditional | PDF ↗ |
| K834525 | ANGIOSCAN FLO MAD SPECTRUM ANALYZER | Unigon Industries, Inc. | 1984-05-23 | Traditional | PDF ↗ |
| K832369 | VASCULAR RECORDER #301 | Imex Medical Systems, Inc. | 1984-03-12 | Traditional | PDF ↗ |
| K833902 | VASOSCAN | Sonicaid, Inc. | 1984-01-27 | Traditional | PDF ↗ |
| K810414 | USCI DOPPLER CATHETER SYSTEM | C.R. Bard, Inc. | 1981-08-12 | Traditional | PDF ↗ |
Product code JOP · Class II · Cardiovascular. Data: openFDA.