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
Jun 12, 1989K893035OPHTHASCAN 'S' MINI-A
Biophysic Medical, Inc.
IYO
Jun 7, 1989K891452SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE
Diasonics, Inc.
IYO
Jun 1, 1989K891453DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V
Toshiba Medical Systems
IYO
May 31, 1989K891225OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1
Canon USA, Inc.
IYO
May 16, 1989K891386CVIS ULTRA-SCAN ONE IMAGING SYSTEM
Cardiovascular Imaging Systems, Inc.
IYO
May 16, 1989K8913095.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
Advanced Technology Laboratories, Inc.
IYO
May 16, 1989K890969TRANSESOPHAGEAL TRANSDUCER PEF-511SA
Toshiba Medical Systems
IYO
May 10, 1989K890772ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.
Boston Scientific Corp
IYO
May 3, 1989K890519LABSONICS MAMM-O-MATE MODEL NO. 918084-1
Laboratory Equipment Corp.
IYO
Apr 14, 1989K890173INTERSPEC APOGEE
Interspec, Inc.
IYO
Mar 31, 1989K883917NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT
Sonomed Technology, Inc.
IYO
Mar 14, 1989K885228RT6800 ECHOCARDIOGRAPHY SYSTEM
General Electric Co.
IYO
Mar 14, 1989K881336BRYMASCAN-A
Brymill Corp.
IYO
Jan 25, 1989K883359DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A
Toshiba Medical Systems
IYO
Jan 13, 1989K884632ACUSON I5100 ULTRASOUND TRANSDUCER
Acuson Corp.
IYO
Jan 10, 1989K884395HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS
Hewlett-Packard Co.
IYO
Jan 10, 1989K884299APA-C CATALOG NUMBER A-8001-C
Ausonics Pty , Ltd.
IYO
Jan 3, 1989K884595OPHTHASCAN MINI-B
Biophysic Medical, Inc.
IYO
Dec 15, 1988K883925UROIMAGER
Ausonics Pty , Ltd.
IYO
Dec 14, 1988K883079WWDS-005 HUMAN RECTAL PROBE
Ausonics Pty , Ltd.
IYO
Dec 12, 1988K875187SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT
Shimadzu Corp., JP
IYO
Dec 1, 1988K883752ACUSON L538 TRANSDUCER
Acuson Corp.
IYO
Nov 29, 1988K881140ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY
Advanced Technology Laboratories, Inc.
IYO
Nov 4, 1988K883481HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE
Hewlett-Packard Co.
IYO
Oct 12, 1988K882478100-01778-52 ULTRASOUND SYSTEM
Diasonics, Inc.
IYO
Oct 7, 1988K883546TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER
Advanced Technology Laboratories, Inc.
IYO
Oct 5, 1988K883965PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR
Teknar, Inc.
IYO
Sep 15, 1988K881889CANON IOL ESTIMATOR KU-1
Canon USA, Inc.
IYO
Aug 29, 1988K881850TEKNAR PERCU-SCAN
Teknar, Inc.
IYO
Aug 25, 1988K874854GPS/WGPS/PREVIEW GP
Labsonics, Inc.
IYO
Aug 24, 1988K883238GENESIS II TRANSCRANIAL PROBE
Biosound, Inc.
IYO
Aug 24, 1988K881834MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Ge Medical Systems Information Technologies
IYO
Aug 19, 1988K882162NIDEK US-3000
Nidek, Inc.
IYO
Aug 18, 1988K882959ENDOVAGINAL PROBE, SMS-510VA
Toshiba Medical Systems
IYO
Aug 12, 1988K882805CILCO VILLASENOR PACHYMETER
Coopervision-Cilco
IYO
Jul 28, 1988K873452MODIFIED MODEL SSD-650 SYSTEM
Ge Medical Systems Information Technologies
IYO
Jul 19, 1988K874192MULTIPURPOSE TRANSDUCER RANGE
Pie Data Medical BV, NL
IYO
Jul 1, 1988K875357BIOPSY FIXATION UNIT-TYPE UA 0997
Bruel & Kjaer Industri A/S, DK
IYO
Jun 23, 1988K874211EUB-450 DIAGNOSTIC ULTRASOUND DEVICE
Hitachi Medical Corp. of America
IYO
Jun 21, 1988K881605BIOPSY GUIDE
Teknar, Inc.
IYO
Jun 21, 1988K874028ACUSON S328 TRANSDUCER
Acuson Computed Sonography
IYO
Jun 10, 1988K880839AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM
Phoenix Imaging
IYO
Jun 8, 1988K880580EXTENDED MULTIPURPOSE TRANSDUCER RANGE
Pie Medical USA BV
IYO
May 16, 1988K881208PROBE SHEATH FOR ADMS ULTRASOUND PROBE
Advanced Diagnostic Medical Systems, Inc.
IYO
May 11, 1988K875251ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE
Philips Medical Systems (Cleveland), Inc.
IYO
May 2, 1988K874363ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.
Acuson Computed Sonography
IYO
Apr 27, 1988K8810287.5 MHZ ENDORECTAL PROBE
Philips Ultrasound, Inc.
IYO
Apr 25, 1988K874685TRANS-SCAN 3-D TRANSCRANIAL DOPPLER
Carolina Medical Electronics
IYO
Apr 25, 1988K874684TC2-64B TRANSCRANIAL DOPPLER
Carolina Medical Electronics
IYO
Apr 21, 1988K880714DIASONICS QT ENDORECTAL 7.5 MHZ PROBE
Diasonics, Inc.
IYO

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