FDA Product Code
FDA Product Code IYO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1560
510(k) Clearances — 895 records · page 6 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K931908 | SONOQUICK ULTRASOUND GEL | Sonomed Technology, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K933320 | CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT | Cardio Metrics, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K926332 | DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIED | B&K Medical | 1994-06-28 | Traditional | PDF ↗ |
| K933056 | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED | B&K Medical | 1994-06-24 | Traditional | PDF ↗ |
| K934205 | SEARCH-SONIC | Altana, Inc. | 1994-06-21 | Traditional | PDF ↗ |
| K926209 | EUB-555 | Hitachi Medical Corp. | 1994-06-03 | Traditional | PDF ↗ |
| K933747 | CAPASEE | Toshiba America Medical Systems, In.C | 1994-05-13 | Traditional | PDF ↗ |
| K930768 | ORION DIAGNOSTIC ULTRASOUND SYSTEM | GE Medical Systems | 1994-03-15 | Traditional | PDF ↗ |
| K930278 | STORZ COMPUSCAN AB | Storz | 1994-02-09 | Traditional | PDF ↗ |
| K934908 | FULL VIEW DIGITAL STORAGE SYSTEM | International Imaging Electronics | 1994-01-28 | Traditional | PDF ↗ |
| K934311 | INTRASCAN(R) MINI-PACS | Markcare Medical Systems, Inc. | 1993-12-13 | Traditional | PDF ↗ |
| K924184 | CVI-Q(TM) OPTION FOR P700 | Philips Medical Systems, Inc. | 1993-12-10 | Traditional | PDF ↗ |
| K924432 | MEDISON 1500 | Medison Co., Ltd. | 1993-11-24 | Traditional | PDF ↗ |
| K923211 | DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE | Zeiss Humphrey System | 1993-11-08 | Traditional | PDF ↗ |
| K930579 | MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM | Medison America, Inc. | 1993-11-03 | Traditional | PDF ↗ |
| K926252 | CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY | Endosonics Corp. | 1993-10-25 | Traditional | PDF ↗ |
| K925627 | ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT | Elscint, Inc. | 1993-10-08 | Traditional | PDF ↗ |
| K924079 | CFM-800 COLOR FLOW MAPPING SYSTEM | Diasonics, Inc. | 1993-09-28 | Traditional | PDF ↗ |
| K926251 | B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM | Biovision, Inc. | 1993-09-14 | Traditional | PDF ↗ |
| K922208 | FUKUDA DENSHI MODEL UF-4500 | Fukuda Denshi USA, Inc. | 1993-08-30 | Traditional | PDF ↗ |
| K926009 | MATRIX CCM 600 | Heraeus Kulzer, Inc. | 1993-07-20 | Traditional | PDF ↗ |
| K930051 | FATHOM CMP-1000 | Fathom Ent., Inc. | 1993-07-20 | Traditional | PDF ↗ |
| K925354 | COMBISON(R) 311 | Kretztechnik AG | 1993-07-08 | Traditional | PDF ↗ |
| K924231 | INTERSPEC APOGEE CLA | Interspec, Inc. | 1993-06-14 | Traditional | PDF ↗ |
| K925965 | PICTURE ARCHIVING AND COMMUNICATION SYSTEMS | Advanced Light Imaging Technologies , Ltd. | 1993-06-14 | Traditional | PDF ↗ |
| K930324 | EZ MOVER | Prime Ideas, Inc. | 1993-06-11 | Traditional | PDF ↗ |
| K923246 | SONACE 2000 | Medison Co., Ltd. | 1993-05-20 | Traditional | PDF ↗ |
| K925646 | SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS. | Aloka Co., Ltd. | 1993-02-12 | Traditional | PDF ↗ |
| K924458 | AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ | Acoustic Imaging Technologies Corp. | 1993-01-21 | Traditional | PDF ↗ |
| K924126 | EUB-405 | Hitachi Medical Systems America, Inc. | 1992-12-10 | Traditional | PDF ↗ |
| K924311 | SONOMED 4000P ULTRASONIC PACHYMETER | Sonomed, Inc. | 1992-12-08 | Traditional | PDF ↗ |
| K923269 | CONVEX AND LINEAR ARRAY TRANSDUCERS | Aloka Co., Ltd. | 1992-12-03 | Traditional | PDF ↗ |
| K921705 | ULTRASONIC PACHYMETER | Precision Corneal Instruments | 1992-11-16 | Traditional | PDF ↗ |
| K920906 | DGH-500 PACHYMETER | Dgh Technology, Inc. | 1992-11-02 | Traditional | PDF ↗ |
| K922605 | TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 | Biodan Medical Systems, Ltd. | 1992-10-20 | Traditional | PDF ↗ |
| K922604 | DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE | Biodan Medical Systems, Ltd. | 1992-10-20 | Traditional | PDF ↗ |
| K904070 | COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A | Kretztechnik AG | 1992-10-09 | Traditional | PDF ↗ |
| K921426 | ULTRA PCI | Advanced Medical Products, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K922647 | COLOR DISKSTORE | Camtronics, Ltd. | 1992-08-11 | Traditional | PDF ↗ |
| K915715 | CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER | Ausonics Pty , Ltd. | 1992-07-02 | Traditional | PDF ↗ |
| K914945 | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED | Bruel & Kjaer Industri A/S | 1992-06-26 | Traditional | PDF ↗ |
| K921670 | ACUSON IMAGE MANAGEMENT SYSTEM | Acuson Corp. | 1992-06-25 | Traditional | PDF ↗ |
| K920373 | MAESTRO DIGITAL VIDEO SYSTEM | International Imaging Electronics | 1992-06-24 | Traditional | PDF ↗ |
| K920374 | ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM | Ge Medical Systems Information Technologies | 1992-04-02 | Traditional | PDF ↗ |
| K915436 | BLADDERSCAN BVI 2500 | Diagnostic Ultrasound Corp. | 1992-03-03 | Traditional | PDF ↗ |
| K913067 | DGH-4000 A-SCAN/PACHYMETER | Dgh Technology, Inc. | 1992-01-31 | Traditional | PDF ↗ |
| K914013 | SIEMENS SI-400 | Siemens Ultrasound, Inc. | 1991-12-02 | Traditional | PDF ↗ |
| K911584 | DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 | Pie Medical Equipment B.V. | 1991-10-24 | Traditional | PDF ↗ |
| K911464 | INTERSON DISPOSABLE BIOPSY NEEDLE | Interson Corp. | 1991-09-27 | Traditional | PDF ↗ |
| K910956 | COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR | Storz Instrument Co. | 1991-09-04 | Traditional | PDF ↗ |
| K910342 | SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Medison Co., Ltd. | 1991-08-19 | Traditional | PDF ↗ |
| K911200 | SI-1200 / ILUS | Siemens Ultrasound, Inc. | 1991-06-17 | Traditional | PDF ↗ |
| K905522 | LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED | Laboratory Equipment Corp. | 1991-06-11 | Traditional | PDF ↗ |
| K911107 | SONARSCAN 128 ULTRASOUND SCANNER | Diagnostic Sonar USA | 1991-06-10 | Traditional | PDF ↗ |
| K904853 | MODEL STT-100 | Sonocare, Inc. | 1991-05-15 | Traditional | PDF ↗ |
| K904019 | QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM | Quantum Medical Systems, Inc. | 1991-03-22 | Traditional | PDF ↗ |
| K903603 | ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) | Advanced Technology Laboratories, Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K905294 | EUB-315 | Hitachi Medical Corp. of America | 1991-02-25 | Traditional | PDF ↗ |
| K896100 | EUB-565 DIAGNOSTIC ULTRASOUND DEVICE | Hitachi Medical Corp. of America | 1991-01-24 | Traditional | PDF ↗ |
| K904692 | DB 3000 A-SCAN SYSTEM | Ocuserv Instruments, Inc. | 1991-01-14 | Traditional | PDF ↗ |
| K903326 | NIDEK US-2000 | Nidek, Inc. | 1990-11-21 | Traditional | PDF ↗ |
| K902214 | BIOPSY NEEDLE TRANSPONDER SYSTEM | Advanced Technology Laboratories, Inc. | 1990-11-08 | Traditional | PDF ↗ |
| K902411 | NIDEK US-2500 W/BIOMETRY UNIT US-2520 | Nidek, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K902965 | FDI 2000 ULTRASONIC SKIN SCANNER | Fulmer Dyson Intl. | 1990-09-26 | Traditional | PDF ↗ |
| K900881 | OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM | Codman & Shurtleff, Inc. | 1990-09-25 | Traditional | PDF ↗ |
| K897042 | EUB-515 DIAGNOSTIC ULTRASOUND DEVICE | Hitachi Medical Corp. of America | 1990-09-13 | Traditional | PDF ↗ |
| K901467 | VISION DIAGNOSTIC ULTRASONIC SCANNER | The Probe Corp. | 1990-09-05 | Traditional | PDF ↗ |
| K900805 | ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM | Ge Medical Systems Information Technologies | 1990-08-23 | Traditional | PDF ↗ |
| K901033 | MER MULTIPLANE RECTAL PROBE (MRP) | Medical Equipment Resources | 1990-08-22 | Traditional | PDF ↗ |
| K896356 | AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM | Esaote Biomedica Spa | 1990-08-21 | Traditional | PDF ↗ |
| K902582 | ALLERGAN HUMPHREY A/B SCAN , MODEL 835 | Allergan Humphrey | 1990-08-14 | Traditional | PDF ↗ |
| K896999 | SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT | Shimadzu Corp. | 1990-08-09 | Traditional | PDF ↗ |
| K902007 | I3SYSTEM-ABD | Innovative Imaging, Inc. | 1990-07-20 | Traditional | PDF ↗ |
| K896480 | SIEMENS SONOLINE AC | Siemens Medical Solutions USA, Inc. | 1990-07-13 | Traditional | PDF ↗ |
| K900469 | ULTRASOUND SCANNER MODEL #1150 | Pie Medical USA BV | 1990-07-09 | Traditional | PDF ↗ |
| K896714 | AUSONICS 5000 | Ausonics Pty , Ltd. | 1990-06-11 | Traditional | PDF ↗ |
| K896755 | ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM | Ge Medical Systems Information Technologies | 1990-05-07 | Traditional | PDF ↗ |
| K884644 | ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U322 | Hitachi Medical Corp. of America | 1990-04-13 | Traditional | PDF ↗ |
| K896173 | ULTRASCAN(R) | Topical Delivery Systems | 1990-04-11 | Traditional | PDF ↗ |
| K895645 | BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM | Biosound, Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K895147 | QUANTUM QAD-1E ANGIODYNOGRAPH ULTRASOUND SYSTEM | Quantum Intl. | 1990-02-23 | Traditional | PDF ↗ |
| K896150 | IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC | Teknar, Inc. | 1990-01-18 | Traditional | PDF ↗ |
| K896029 | DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20 | G.W.B. Intl., Ltd. | 1990-01-12 | Traditional | PDF ↗ |
| K895614 | CIVCO LATEX ULTRASOUND SHEATHS | CIVCO Medical Instruments Co., Inc. | 1989-12-14 | Traditional | PDF ↗ |
| K895071 | AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER | Acoustic Imaging | 1989-10-12 | Traditional | PDF ↗ |
| K893225 | COUPLANT WARMING DEVICE | Echo Ultrasound | 1989-10-12 | Traditional | PDF ↗ |
| K891449 | SONOLINE CF | Siemens Ultrasound, Inc. | 1989-10-05 | Traditional | PDF ↗ |
| K894806 | SIEMENS ENDO-P-PROBE | Siemens Medical Solutions USA, Inc. | 1989-10-05 | Traditional | PDF ↗ |
| K894834 | DERMASCAN C, AN ULTRASONIC DIAGNOSTIC SYSTEM | Brymill Corp. | 1989-10-02 | Traditional | PDF ↗ |
| K893996 | CUSIS ULTRASOUND SKIN IMAGING SYSTEM | Stiefel Research Institute, Inc. | 1989-09-21 | Traditional | PDF ↗ |
| K892386 | DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A | Toshiba America Medical Systems, In.C | 1989-09-12 | Traditional | PDF ↗ |
| K890913 | SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT | Shimadzu Precision Instruments, Inc. | 1989-09-06 | Traditional | PDF ↗ |
| K893837 | CVIS ULTRA-SCAN ONE IMAGING CATHETER | Cardiovascular Imaging Systems, Inc. | 1989-08-22 | Traditional | PDF ↗ |
| K890275 | ACUSON S328 TRANSDUCER FOR FETAL CARDIAC PULSED | Acuson Corp. | 1989-07-31 | Traditional | PDF ↗ |
| K884271 | ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER | Acuson Corp. | 1989-07-27 | Traditional | PDF ↗ |
| K892355 | M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ | Hewlett-Packard Co. | 1989-07-24 | Traditional | PDF ↗ |
| K890963 | SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 | Esaote Biomedica Elettronica | 1989-07-19 | Traditional | PDF ↗ |
| K893035 | OPHTHASCAN 'S' MINI-A | Biophysic Medical, Inc. | 1989-06-12 | Traditional | PDF ↗ |
| K891452 | SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE | Diasonics, Inc. | 1989-06-07 | Traditional | PDF ↗ |
| K891453 | DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V | Toshiba Medical Systems | 1989-06-01 | Traditional | PDF ↗ |
Product code IYO · Class II · Radiology. Data: openFDA.