FDA Product Code
FDA Product Code IYN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1550
510(k) Clearances — 1,186 records · page 12 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K981397 | HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 | Toshiba America Medical Systems, In.C | 1998-07-31 | Traditional | PDF ↗ |
| K973556 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 | Imex Medical Systems, Inc. | 1998-04-24 | Traditional | PDF ↗ |
| K980557 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING | Siemens Medical Solutions USA, Inc. | 1998-04-24 | Traditional | PDF ↗ |
| K973562 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 | Imex Medical Systems, Inc. | 1998-04-15 | Traditional | PDF ↗ |
| K971790 | KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) | Urometrics, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K960527 | LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM | GE Medical Systems | 1997-09-08 | Traditional | PDF ↗ |
| K972465 | ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 1997-08-15 | Traditional | PDF ↗ |
| K964886 | GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM | GE Medical Systems | 1997-07-29 | Traditional | PDF ↗ |
| K954220 | EUB-8000 | Hitachi Medical Corp. of America | 1997-05-07 | Traditional | PDF ↗ |
| K964309 | SONOS 2000, SONOS 2500 (M2406 A) | Hewlett-Packard Co. | 1997-04-22 | Traditional | PDF ↗ |
| K963616 | ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 1997-04-03 | Traditional | PDF ↗ |
| K964699 | RHEO DOPPLEX II (RD 2) | Huntleigh Technology, Inc. | 1997-02-21 | Traditional | PDF ↗ |
| K962796 | NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM | Medasonics, Inc. | 1997-01-21 | Traditional | PDF ↗ |
| K963705 | COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A | Toshiba America Medical Systems, In.C | 1996-12-02 | Traditional | PDF ↗ |
| K954028 | HP SONOS ULTRASOUND IMAGING SYSTEM | Hewlett-Packard Co. | 1996-08-08 | Traditional | PDF ↗ |
| K935024 | ESI-5000 | Elscint, Inc. | 1996-06-12 | Traditional | PDF ↗ |
| K945957 | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER | Kleinfeld, Kaplan and Becker | 1996-04-15 | Traditional | PDF ↗ |
| K955327 | HP SONOS 100CF ULTRASOUND IMAGING SYSTEM | Hewlett-Packard Co. | 1996-04-08 | Traditional | PDF ↗ |
| K951998 | DIASONICS MASTERS SERIES 5000 ULTRASOUND SCANNER | Diasonics Ultrasound | 1996-03-27 | Traditional | PDF ↗ |
| K960602 | SSA-340A (MODIFICATION) | Toshiba America Medical Systems, In.C | 1996-03-21 | Traditional | PDF ↗ |
| K946277 | TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM | Tetra Corp. | 1996-03-15 | Traditional | PDF ↗ |
| K954022 | ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM | Aloka Co., Ltd. | 1996-01-17 | Traditional | PDF ↗ |
| K941352 | SSA-340A | Toshiba America Medical Systems, In.C | 1995-12-22 | Traditional | PDF ↗ |
| K945072 | SIEMENS Q4000 | Siemens Medical Solutions USA, Inc. | 1995-11-21 | Traditional | PDF ↗ |
| K936067 | ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM | Atlantis Diagnostics Intl., Inc. | 1995-10-27 | Traditional | PDF ↗ |
| K945773 | SIEMENS SONOLINE VERSA | Siemens Medical Solutions USA, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K951695 | OPERAND* ULTRASOUND TRANSMISSION GEL | Redi Products, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K944048 | ULTRASOUND 77030 IMAGING SYSTEM | Hewlett-Packard Co. | 1995-03-01 | Traditional | PDF ↗ |
| K930458 | MULTI-DOP L | Dantec Medical, Inc. | 1995-02-03 | Traditional | PDF ↗ |
| K943863 | NEEDLE GUIDE | Biopsys Medical, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K935923 | PHILIPS ULTRASOUND P800 IMAGING SYSTEM | Hewlett-Packard Co. | 1994-12-08 | Traditional | PDF ↗ |
| K934915 | ACUSON MODEL 2001 | Acuson Corp. | 1994-10-21 | Traditional | PDF ↗ |
| K941652 | ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION | Aloka Co., Ltd. | 1994-10-21 | Traditional | PDF ↗ |
| K933743 | SSA-380A | Toshiba America Medical Systems, In.C | 1994-10-20 | Traditional | PDF ↗ |
| K935009 | PEGASUS | Advanced Technology Laboratories, Inc. | 1994-10-11 | Traditional | PDF ↗ |
| K933916 | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER | Ausonics Pty , Ltd. | 1994-10-03 | Traditional | PDF ↗ |
| K934041 | HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION | Hewlett-Packard Co. | 1994-09-22 | Traditional | PDF ↗ |
| K933202 | VENUS DIAGNOSTIC ULTRASOUND SYSTEM | GE Medical Systems | 1994-06-27 | Traditional | PDF ↗ |
| K915403 | DIAGNOSTIC ULTRASOUND SYSTEM | Hitachi Medical Systems America, Inc. | 1994-05-03 | Traditional | PDF ↗ |
| K940285 | ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION | Acuson Corp. | 1994-04-29 | Traditional | PDF ↗ |
| K931293 | SSH-140A FETAL DOPPLER SYSTEM | Toshiba America Medical Systems, In.C | 1994-02-09 | Traditional | PDF ↗ |
| K926351 | COLORMARK(TM) VISUALIZATION SYSTEM | Echocath, Inc. | 1993-09-16 | Traditional | PDF ↗ |
| K924204 | NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS | Tetra Corp. | 1993-06-07 | Traditional | PDF ↗ |
| K914862 | CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS | Medasonics, Inc. | 1992-12-03 | Traditional | PDF ↗ |
| K912819 | SC1150 CW/PD | Pie Medical Equipment B.V. | 1992-01-09 | Traditional | PDF ↗ |
| K905198 | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 | Bruel & Kjaer | 1991-08-28 | Traditional | PDF ↗ |
| K904017 | SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES | Siemens Ultrasound, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K904359 | ESI-3000 ULTRASOUND SYSTEM | Elscint, Inc. | 1991-03-05 | Traditional | PDF ↗ |
| K902691 | DOPPLER OPTION FOR PLATINUM | Philips Medical Systems, Inc. | 1991-01-02 | Traditional | PDF ↗ |
| K901329 | CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM | Advanced Technology Laboratories, Inc. | 1990-11-23 | Traditional | PDF ↗ |
| K893861 | TMI LW-100 PULSED DOPPLER SYSTEM | Titronics Medical Instruments, Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K894163 | PHASE 2 TRANSCRANIAL PROBE | Biosound, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K894054 | 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | 1989-09-12 | Traditional | PDF ↗ |
| K893833 | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER | Acoustic Imaging | 1989-09-11 | Traditional | PDF ↗ |
| K893042 | CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM | Endosonics Corp. | 1989-07-19 | Traditional | PDF ↗ |
| K885211 | RF-100 MONITOR, RF-P-2.5, RF-P-5, RF-P-7.5 PROBES | Rf Design Assoc., Inc. | 1989-06-13 | Traditional | PDF ↗ |
| K891238 | SIEMENS TRANSESOPHAGEAL ECHO TEE TRANSDUCER | Siemens Ultrasound, Inc. | 1989-06-05 | Traditional | PDF ↗ |
| K890055 | ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER | Acuson Corp. | 1989-05-16 | Traditional | PDF ↗ |
| K890998 | QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL. | Quantum Medical Systems, Inc. | 1989-05-02 | Traditional | PDF ↗ |
| K885155 | MENTOR MDS | Imex | 1989-03-14 | Traditional | PDF ↗ |
| K882585 | CAVROLAB | Life-Tech Intl., Inc. | 1989-03-02 | Traditional | PDF ↗ |
| K882755 | MODEL 500V VASCULAR SPECTRUM ANALYZER | Multigon Industries, Inc. | 1988-11-29 | Traditional | PDF ↗ |
| K882015 | TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM | Ultramed, Inc. | 1988-09-08 | Traditional | PDF ↗ |
| K882737 | ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER | Acuson Corp. | 1988-09-08 | Traditional | PDF ↗ |
| K872817 | 5 MHZ DOPPLER OUTRIGGER | Philips Ultrasound, Inc. | 1988-02-08 | Traditional | PDF ↗ |
| K872292 | TRANSPECT TRANSCRANIAL DOPPLER | Medasonics, Inc. | 1987-08-14 | Traditional | PDF ↗ |
| K863577 | DOPPLER UNIT, SDS-100A | Toshiba Medical Systems | 1987-02-25 | Traditional | PDF ↗ |
| K850071 | TECA MF-20 MICROVASCULAR DOPPLER | Teca, Inc. | 1985-04-02 | Traditional | PDF ↗ |
| K842407 | PULSED DOPPLER OPTION, CONTINU-WAVE | General Electric Co. | 1985-02-13 | Traditional | PDF ↗ |
| K844293 | AUTO DII MULTI FREQUENCY | Technicare Corp. | 1985-02-13 | Traditional | PDF ↗ |
| K842055 | PICKER ARTIS ULTRASOUND IMAGING SYS | Philips Medical Systems (Cleveland), Inc. | 1984-08-24 | Traditional | PDF ↗ |
| K840140 | DOPPLER IMAGING OPTION | Hewlett-Packard Co. | 1984-08-23 | Traditional | PDF ↗ |
| K840953 | ACCESS SCANHEADSS | Advanced Technology Laboratories, Inc. | 1984-06-15 | Traditional | PDF ↗ |
| K840402 | AUDIO BANDWIDTH ANALYZER | D. E. Hokanson, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K813544 | IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. | Irex Corp. | 1982-02-05 | Traditional | PDF ↗ |
| K812606 | SECTORTAC | Echo Laboratories, Inc. | 1981-10-13 | Traditional | PDF ↗ |
| K810133 | ULTRAPROBE | Ars Magna | 1981-06-09 | Traditional | PDF ↗ |
| K810118 | LS1000 ELECTRONIC FOCUS | Philips Medical Systems (Cleveland), Inc. | 1981-02-19 | Traditional | PDF ↗ |
| K803246 | ULTRASONIC STETHOSCOPE | Sonicaid, Inc. | 1981-01-28 | Traditional | PDF ↗ |
| K802979 | DIASONICS SMALL PARTS SCANNER | Diasonics, Inc. | 1981-01-22 | Traditional | PDF ↗ |
| K802254 | GENERAL ULTRASOUND EXAM. TABLE | Engineering Dynamics Corp. | 1980-11-26 | Traditional | PDF ↗ |
| K801972 | TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX | Advanced Technology Laboratories, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K801655 | AUTO SECTOR SCANNER | Unirad Corp. | 1980-09-26 | Traditional | PDF ↗ |
| K801656 | EDP 1200 SECTOR SCANNER OPTION | Unirad Corp. | 1980-09-26 | Traditional | PDF ↗ |
| K801512 | DOPPLER ULTRASONIC STETHOSCOPE | Mountain Medical Equipment, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K781642 | RA-I | Diasonics, Inc. | 1978-10-10 | Traditional | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.