ClearanceBrief
Panels › Radiology › Product code ITX · Class 2

Transducer, Ultrasonic, Diagnostic

Regulation 892.1570

6510(k)s in 12 months (415 all time)
13recalls in 12 months (147 all time)
118recalls that name a 510(k)
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Top companies in ITX

Decided510(k)Device and applicantCode
Feb 23, 1995K921695ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS
Parker Laboratories, Inc.
ITX
Jan 4, 1995K930052SIEMENS QUANTUM 7E11 TRANSRECTAL TRANSDUCER
Siemens Quantum, Inc.
ITX
Dec 29, 1994K943637SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
ITX
Dec 7, 1994K940108DIAGNOSTIC ULTRASOUND IMAGING CATHETER
Boston Scientific Corp
ITX
Nov 22, 1994K940671INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER
Interspec, Inc.
ITX
Jun 10, 1994K940804SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION
Peripheral Systems Group
ITX
Jan 21, 1994K933663MODIFICATION OF ACUSON V510B TRANSDUCER
Acuson Corp.
ITX
Jan 6, 1994K925869SHEATHES, STERILE SHEATHES
Mayer Laboratories
ITX
Oct 7, 1993K932777SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER
Peripheral Systems Group
ITX
Sep 30, 1993K925434SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A
Kretz Technik
ITX
Sep 28, 1993K932536CARDIOMETRICS FLOWIRE & FLOMAP
Cardio Metrics, Inc.
ITX
Sep 28, 1993K925081SURFAS
D.O. Weaver and Co.
ITX
Sep 24, 1993K926108VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800
Vingmed Sound, Inc., NO
ITX
Mar 26, 1993K920882ACUSON V714 TRANSDUCER
Acuson Corp.
ITX
Feb 12, 1993K925486UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.
Aloka Co., Ltd.
ITX
Jan 15, 1993K924980CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH
Endosonics Corp.
ITX
Dec 10, 1992K923348OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED
Zeiss Humphrey System
ITX
Nov 27, 1992K921341ACUSON V714OR TRANSDUCER
Acuson Corp.
ITX
Nov 24, 1992K915696INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE
Interspec, Inc.
ITX
Nov 9, 1992K915647DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250
Pie Medical Equipment B.V., NL
ITX
Nov 9, 1992K913890SONICATH(TM) 3.5 F, 20 MHZ
Boston Scientific Corp
ITX
Sep 21, 1992K922549UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35
Aloka Co., Ltd.
ITX
Sep 11, 1992K911435CPA/3.5 MHZ PROBE
Diasonics, Inc.
ITX
Sep 4, 1992K902515ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP
Acuson Corp.
ITX
Aug 26, 1992K912364ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED
Hitachi Medical Corp. of America
ITX
Jul 30, 1992K922184HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM
Hewlett-Packard Co.
ITX
Jul 13, 1992K921750CVIS INSIGHT III SYSTEM
Cardiovascular Imaging Systems, Inc.
ITX
Jul 2, 1992K921631CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL
Cardiovascular Imaging Systems, Inc.
ITX
Jul 2, 1992K915860LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE
Biosound, Inc.
ITX
Jul 1, 1992K921563CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM
Cardio Metrics, Inc.
ITX
Jun 18, 1992K911916ACUSON C366 TRANSDUCER
Acuson Corp.
ITX
Jun 16, 1992K921148CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE
Cardiovascular Imaging Systems, Inc.
ITX
Jun 16, 1992K921147CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE
Cardiovascular Imaging Systems, Inc.
ITX
May 29, 1992K921036SONOS 100 ULTRASOUND IMAGING SYSTEM
Hewlett-Packard Co.
ITX
May 19, 1992K920307AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION
Ausonics Pty , Ltd.
ITX
Apr 17, 1992K910966SECTOR TRANSDUCER MODEL NO. AWP3.5/A
Kretztechnik AG, AT
ITX
Apr 2, 1992K920678ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER
Interspec, Inc.
ITX
Apr 2, 1992K914006BIPLANE TRANSRECTAL PROBE
Biosound, Inc.
ITX
Apr 2, 1992K905200SACA, 3.5 MHZ PROBE
Diasonics, Inc.
ITX
Apr 1, 1992K913798SONOLAYER ALPHA, MODEL SSH-140A
Toshiba America Medical Systems, In.C
ITX
Mar 13, 1992K913472LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM
Baxter Healthcare Corp
ITX
Mar 2, 1992K903562CW DOPPLER 2.25 MHZ PROBE
Diasonics, Inc.
ITX
Feb 27, 1992K913941PSG(TM) 20 GUAGE DOPPLER NEEDLE
Peripheral Systems Group
ITX
Jan 29, 1992K910850PSF-50ET
Toshiba America Medical Systems, In.C
ITX
Jan 9, 1992K912776CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND
Cardio Metrics, Inc.
ITX
Dec 20, 1991K911116INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST
Interson Corp.
ITX
Dec 17, 1991K913746SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM
Peripheral Systems Group
ITX
Dec 17, 1991K911117INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYST
Interson Corp.
ITX
Dec 17, 1991K911115INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM
Interson Corp.
ITX
Dec 17, 1991K911113INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYST
Interson Corp.
ITX

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