ClearanceBrief
Panels › Radiology › Product code IYO · Class 2

System, Imaging, Pulsed Echo, Ultrasonic

Regulation 892.1560

11510(k)s in 12 months (898 all time)
9recalls in 12 months (83 all time)
80recalls that name a 510(k)
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Top companies in IYO

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.3111
Volcano Corporation1917
CIVCO Medical Instruments Co., Inc.717
General Electric Co.210
Advanced Technology Laboratories, Inc.200
Hewlett-Packard Co.140
GE Medical Systems112
Ausonics Pty , Ltd.120
Hitachi Medical Corp. of America120
Toshiba Medical Systems120
Decided510(k)Device and applicantCode
Oct 24, 1991K911584DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480
Pie Medical Equipment B.V., NL
IYO
Sep 27, 1991K911464INTERSON DISPOSABLE BIOPSY NEEDLE
Interson Corp.
IYO
Sep 4, 1991K910956COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR
Storz Instrument Co.
IYO
Aug 19, 1991K910342SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Medison Co., Ltd., KR
IYO
Jun 17, 1991K911200SI-1200 / ILUS
Siemens Ultrasound, Inc.
IYO
Jun 11, 1991K905522LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED
Laboratory Equipment Corp.
IYO
Jun 10, 1991K911107SONARSCAN 128 ULTRASOUND SCANNER
Diagnostic Sonar USA
IYO
May 15, 1991K904853MODEL STT-100
Sonocare, Inc.
IYO
Mar 22, 1991K904019QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM
Quantum Medical Systems, Inc.
IYO
Feb 26, 1991K903603ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9)
Advanced Technology Laboratories, Inc.
IYO
Feb 25, 1991K905294EUB-315
Hitachi Medical Corp. of America
IYO
Jan 24, 1991K896100EUB-565 DIAGNOSTIC ULTRASOUND DEVICE
Hitachi Medical Corp. of America
IYO
Jan 14, 1991K904692DB 3000 A-SCAN SYSTEM
Ocuserv Instruments, Inc.
IYO
Nov 21, 1990K903326NIDEK US-2000
Nidek, Inc.
IYO
Nov 8, 1990K902214BIOPSY NEEDLE TRANSPONDER SYSTEM
Advanced Technology Laboratories, Inc.
IYO
Oct 9, 1990K902411NIDEK US-2500 W/BIOMETRY UNIT US-2520
Nidek, Inc.
IYO
Sep 26, 1990K902965FDI 2000 ULTRASONIC SKIN SCANNER
Fulmer Dyson Intl.
IYO
Sep 25, 1990K900881OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM
Codman & Shurtleff, Inc.
IYO
Sep 13, 1990K897042EUB-515 DIAGNOSTIC ULTRASOUND DEVICE
Hitachi Medical Corp. of America
IYO
Sep 5, 1990K901467VISION DIAGNOSTIC ULTRASONIC SCANNER
The Probe Corp.
IYO
Aug 23, 1990K900805ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
Ge Medical Systems Information Technologies
IYO
Aug 22, 1990K901033MER MULTIPLANE RECTAL PROBE (MRP)
Medical Equipment Resources
IYO
Aug 21, 1990K896356AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM
Esaote Biomedica Spa
IYO
Aug 14, 1990K902582ALLERGAN HUMPHREY A/B SCAN , MODEL 835
Allergan Humphrey
IYO
Aug 9, 1990K896999SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT
Shimadzu Corp.
IYO
Jul 20, 1990K902007I3SYSTEM-ABD
Innovative Imaging, Inc.
IYO
Jul 13, 1990K896480SIEMENS SONOLINE AC
Siemens Medical Solutions USA, Inc.
IYO
Jul 9, 1990K900469ULTRASOUND SCANNER MODEL #1150
Pie Medical USA BV
IYO
Jun 11, 1990K896714AUSONICS 5000
Ausonics Pty , Ltd.
IYO
May 7, 1990K896755ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
Ge Medical Systems Information Technologies
IYO
Apr 13, 1990K884644ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U322
Hitachi Medical Corp. of America
IYO
Apr 11, 1990K896173ULTRASCAN(R)
Topical Delivery Systems
IYO
Mar 6, 1990K895645BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM
Biosound, Inc.
IYO
Feb 23, 1990K895147QUANTUM QAD-1E ANGIODYNOGRAPH ULTRASOUND SYSTEM
Quantum Intl.
IYO
Jan 18, 1990K896150IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC
Teknar, Inc.
IYO
Jan 12, 1990K896029DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20
G.W.B. Intl., Ltd.
IYO
Dec 14, 1989K895614CIVCO LATEX ULTRASOUND SHEATHS
CIVCO Medical Instruments Co., Inc.
IYO
Oct 12, 1989K895071AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER
Acoustic Imaging
IYO
Oct 12, 1989K893225COUPLANT WARMING DEVICE
Echo Ultrasound
IYO
Oct 5, 1989K894806SIEMENS ENDO-P-PROBE
Siemens Medical Solutions USA, Inc.
IYO
Oct 5, 1989K891449SONOLINE CF
Siemens Ultrasound, Inc.
IYO
Oct 2, 1989K894834DERMASCAN C, AN ULTRASONIC DIAGNOSTIC SYSTEM
Brymill Corp.
IYO
Sep 21, 1989K893996CUSIS ULTRASOUND SKIN IMAGING SYSTEM
Stiefel Research Institute, Inc.
IYO
Sep 12, 1989K892386DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A
Toshiba America Medical Systems, In.C
IYO
Sep 6, 1989K890913SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT
Shimadzu Precision Instruments, Inc.
IYO
Aug 22, 1989K893837CVIS ULTRA-SCAN ONE IMAGING CATHETER
Cardiovascular Imaging Systems, Inc.
IYO
Jul 31, 1989K890275ACUSON S328 TRANSDUCER FOR FETAL CARDIAC PULSED
Acuson Corp.
IYO
Jul 27, 1989K884271ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER
Acuson Corp.
IYO
Jul 24, 1989K892355M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ
Hewlett-Packard Co., DE
IYO
Jul 19, 1989K890963SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4
Esaote Biomedica Elettronica
IYO

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