System, Imaging, Pulsed Echo, Ultrasonic

FDA product code IYO · 862 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1560
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-08-03 – 2026-09-24

IYO 1997-05-29

HR12000 ULTRASOUND SYSTEM

Applicant International Ultrasound Corp.

K number K961229

View details →

IYO 1997-04-24

SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K962882

View details →

IYO 1997-04-21

JANUS I

Applicant 3D Ultrasound, Inc.

K number K963863

View details →

IYO 1997-04-04

IMEX FUTURALDOP PRO

Applicant Imex Medical Systems, Inc.

K number K970156

View details →

IYO 1997-03-26

LEVEL 10 HDI

Applicant Advanced Technology Laboratories, Inc.

K number K961459

View details →

IYO 1997-03-19

PHILIPS SONO DIAGNOST 800

Applicant Hewlett-Packard Co.

K number K963706

View details →

IYO 1997-03-17

VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE

Applicant Vingmed Sound, Inc.

K number K963315

View details →

IYO 1997-02-19

ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)

Applicant Atlantis Diagnostics Intl., Inc.

K number K961073

View details →

IYO 1997-02-19

COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER

Applicant Medison America, Inc.

K number K940942

View details →

IYO 1997-02-11

ULTRASOUND SYSTEM MODEL UF-3500

Applicant Fukuda Denshi USA, Inc.

K number K955543

View details →

IYO 1997-01-02

VINGMED SOUND COLOR FLOW MAPPING SYSTEM

Applicant Diasonics, Inc.

K number K962662

View details →

IYO 1996-12-18

TOMTEC ECHO-SCAN

Applicant Tomtec Imaging Systems, Inc.

K number K963807

View details →

IYO 1996-10-31

V-LINK 3.2 FOR WINDOWS

Applicant Koven Technology, Inc.

K number K963274

View details →

IYO 1996-10-29

SONOLINE ELEGRA WITH SIESCAPE FEATURE

Applicant Siemens Medical Solutions USA, Inc.

K number K961833

View details →

IYO 1996-10-01

BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000

Applicant Diagnostic Ultrasound Corp.

K number K963585

View details →

IYO 1996-08-28

LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant GE Medical Systems

K number K960700

View details →

IYO 1996-08-08

FIRST BEAT/CARDIO BEAT/CALC

Applicant Medasonics, Inc.

K number K961116

View details →

IYO 1996-08-08

MENTOR ADVENT A/B SYSTEM

Applicant Mentor Ophthalmics, Inc.

K number K960765

View details →

IYO 1996-07-26

ECHO. AKHO

Applicant Alliance Medical, Inc.

K number K951976

View details →

IYO 1996-07-25

KILTEX PROBE COVER

Applicant Kiltex Corp.

K number K961029

View details →

IYO 1996-07-17

EUB-905

Applicant Hitachi Medical Corp. of America

K number K962308

View details →

IYO 1996-05-28

PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065

Applicant Vingmed Sound, Inc.

K number K954884

View details →

IYO 1996-05-24

BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000

Applicant Diagnostic Ultrasound Corp.

K number K955840

View details →

IYO 1996-05-24

STENODOC

Applicant Specs USA, Inc.

K number K946349

View details →

IYO 1996-05-20

MODEL KM-25

Applicant Koven Technology, Inc.

K number K951449

View details →

IYO 1996-05-17

DIAGNOSTIC ULTRASONIC TRANSDUCER

Applicant Toshiba America Medical Systems, In.C

K number K941593

View details →

IYO 1996-05-13

I-SCAN

Applicant Ophthalmic Technologies, Inc.

K number K960622

View details →

IYO 1996-05-07

DIGITAL IMAGE ACQUISITION SYSTEM

Applicant International Imaging Electronics

K number K950330

View details →

IYO 1996-04-15

OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER

Applicant Olympus America, Inc.

K number K951994

View details →

IYO 1996-04-08

DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

Applicant Biosound, Inc.

K number K953530

View details →

IYO 1996-04-05

SIEMENS Q64XXX

Applicant Siemens Medical Solutions USA, Inc.

K number K950157

View details →

IYO 1996-03-15

BLADDERSCAN BVI 5000

Applicant Diagnostic Ultrasound Corp.

K number K955942

View details →

IYO 1996-03-15

RT55 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant General Electric Co.

K number K953752

View details →

IYO 1996-03-14

6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE

Applicant Medison America, Inc.

K number K953773

View details →

IYO 1996-03-14

ECLIPSE PROBE COVER

Applicant Parker Laboratories, Inc.

K number K953673

View details →

IYO 1996-03-11

SONOS IMAGING SYSTEM (2000/2500 & 1000/1500)

Applicant Hewlett-Packard Co.

K number K952540

View details →

IYO 1996-03-07

ULTRA EASE

Applicant Lectec Corp.

K number K950943

View details →

IYO 1996-02-13

SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Shimadzu Medical Systems

K number K953634

View details →

IYO 1996-02-09

ULTRASOUND SCANNER 2002

Applicant B&K Medical

K number K943315

View details →

IYO 1996-01-05

HOLOPSY SYSTEM

Applicant Neovision Corp.

K number K951999

View details →

IYO 1995-12-11

JANUS I

Applicant 3D Ultrasound, Inc.

K number K952551

View details →

IYO 1995-11-09

EXAMINATION PAD

Applicant Inventive Products, Inc.

K number K955094

View details →

IYO 1995-11-03

IMEX 8000 PERSONAL CASCULAR LAB

Applicant Imex Medical Systems, Inc.

K number K942243

View details →

IYO 1995-10-27

EUB-555A+

Applicant Hitachi Medical Corp. of America

K number K945795

View details →

IYO 1995-10-17

SONOGEL

Applicant Sonotech, Inc.

K number K953468

View details →

IYO 1995-10-03

SIEMENS SONOLINE 4XX

Applicant Siemens Medical Solutions USA, Inc.

K number K946179

View details →

IYO 1995-09-22

MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM

Applicant Endosonics Corp.

K number K950276

View details →

IYO 1995-08-22

ULTRASOUND SCANNER 2001

Applicant B & K Medical A/S

K number K936024

View details →

IYO 1995-07-27

ECHO-SCAN

Applicant Tomographic Tech

K number K941322

View details →

IYO 1995-07-12

DICOMIT

Applicant Dicomit Imaging Systems Corp.

K number K951925

View details →

IYO 1995-06-21

GRAHAM-FIELD ULTRASOUND SCANNING GEL

Applicant Chester Labs, Inc.

K number K944597

View details →

IYO 1995-06-19

MULTI-DOP S

Applicant Dantec Medical, Inc.

K number K926363

View details →

IYO 1995-06-14

MULTI-DOP X

Applicant Dantec Medical, Inc.

K number K931801

View details →

IYO 1995-05-24

4000 AU ULTRASOUND IMAGING SYSTEM

Applicant Biosound, Inc.

K number K944485

View details →

IYO 1995-05-04

VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)

Applicant Endosonics Corp.

K number K944004

View details →

IYO 1995-02-03

PVK-357AT

Applicant Toshiba America Medical Systems, In.C

K number K943303

View details →

IYO 1995-02-01

SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Aloka Co., Ltd.

K number K943113

View details →

IYO 1995-01-25

TOMTEC ECHO-VIEW

Applicant Tomtec Tomographic Technologies GmbH

K number K934139

View details →

IYO 1994-12-27

MEDISON 4800

Applicant Medison America, Inc.

K number K925582

View details →

IYO 1994-12-27

AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Acoustic Imaging Technologies Corp.

K number K923273

View details →

IYO 1994-12-15

HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER

Applicant Humphrey, Inc.

K number K944523

View details →

IYO 1994-11-14

ULTRASOUND PROBE DRAPE

Applicant Hydro-Med Products, Inc.

K number K940151

View details →

IYO 1994-11-14

SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.

Applicant Shimadzu Medical Systems

K number K931021

View details →

IYO 1994-10-26

ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)

Applicant Acuson Corp.

K number K930964

View details →

IYO 1994-10-03

SWEMED NEEDLE GUIDE

Applicant Swemed Lab Intl.

K number K925999

View details →

IYO 1994-09-30

HP 77010CF

Applicant Hewlett-Packard Co.

K number K943634

View details →

IYO 1994-09-29

CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL

Applicant Sonomed Technology, Inc.

K number K931909

View details →

IYO 1994-09-29

SONOQUICK ULTRASOUND GEL

Applicant Sonomed Technology, Inc.

K number K931908

View details →

IYO 1994-08-17

CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT

Applicant Cardio Metrics, Inc.

K number K933320

View details →

IYO 1994-06-28

DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIED

Applicant B&K Medical

K number K926332

View details →

IYO 1994-06-24

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED

Applicant B&K Medical

K number K933056

View details →

IYO 1994-06-21

SEARCH-SONIC

Applicant Altana, Inc.

K number K934205

View details →

IYO 1994-06-03

EUB-555

Applicant Hitachi Medical Corp.

K number K926209

View details →

IYO 1994-05-13

CAPASEE

Applicant Toshiba America Medical Systems, In.C

K number K933747

View details →

IYO 1994-03-15

ORION DIAGNOSTIC ULTRASOUND SYSTEM

Applicant GE Medical Systems

K number K930768

View details →

IYO 1994-02-09

STORZ COMPUSCAN AB

Applicant Storz

K number K930278

View details →

IYO 1994-01-28

FULL VIEW DIGITAL STORAGE SYSTEM

Applicant International Imaging Electronics

K number K934908

View details →

IYO 1993-12-13

INTRASCAN(R) MINI-PACS

Applicant Markcare Medical Systems, Inc.

K number K934311

View details →

IYO 1993-12-10

CVI-Q(TM) OPTION FOR P700

Applicant Philips Medical Systems, Inc.

K number K924184

View details →

IYO 1993-11-24

MEDISON 1500

Applicant Medison Co., Ltd.

K number K924432

View details →

IYO 1993-11-08

DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE

Applicant Zeiss Humphrey System

K number K923211

View details →

IYO 1993-11-03

MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM

Applicant Medison America, Inc.

K number K930579

View details →

IYO 1993-10-25

CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY

Applicant Endosonics Corp.

K number K926252

View details →

IYO 1993-10-08

ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT

Applicant Elscint, Inc.

K number K925627

View details →

IYO 1993-09-28

CFM-800 COLOR FLOW MAPPING SYSTEM

Applicant Diasonics, Inc.

K number K924079

View details →

IYO 1993-09-14

B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM

Applicant Biovision, Inc.

K number K926251

View details →

IYO 1993-08-30

FUKUDA DENSHI MODEL UF-4500

Applicant Fukuda Denshi USA, Inc.

K number K922208

View details →

IYO 1993-07-20

FATHOM CMP-1000

Applicant Fathom Ent., Inc.

K number K930051

View details →

IYO 1993-07-20

MATRIX CCM 600

Applicant Heraeus Kulzer, Inc.

K number K926009

View details →

IYO 1993-07-08

COMBISON(R) 311

Applicant Kretztechnik AG

K number K925354

View details →

IYO 1993-06-14

PICTURE ARCHIVING AND COMMUNICATION SYSTEMS

Applicant Advanced Light Imaging Technologies , Ltd.

K number K925965

View details →

IYO 1993-06-14

INTERSPEC APOGEE CLA

Applicant Interspec, Inc.

K number K924231

View details →

IYO 1993-06-11

EZ MOVER

Applicant Prime Ideas, Inc.

K number K930324

View details →

IYO 1993-05-20

SONACE 2000

Applicant Medison Co., Ltd.

K number K923246

View details →

IYO 1993-02-12

SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS.

Applicant Aloka Co., Ltd.

K number K925646

View details →

IYO 1993-01-21

AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ

Applicant Acoustic Imaging Technologies Corp.

K number K924458

View details →

IYO 1992-12-10

EUB-405

Applicant Hitachi Medical Systems America, Inc.

K number K924126

View details →

IYO 1992-12-08

SONOMED 4000P ULTRASONIC PACHYMETER

Applicant Sonomed, Inc.

K number K924311

View details →

IYO 1992-12-03

CONVEX AND LINEAR ARRAY TRANSDUCERS

Applicant Aloka Co., Ltd.

K number K923269

View details →

IYO 1992-11-16

ULTRASONIC PACHYMETER

Applicant Precision Corneal Instruments

K number K921705

View details →