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

Decided510(k)Device and applicantCode
Apr 18, 1988K874683THE ESI-2000 ULTRASOUND UNIT
Elscint, Inc.
IYO
Apr 18, 1988K874548SIM 4000C
Ote-Biomedica Elettronica S.P.A
IYO
Apr 15, 1988K875240TRANS/V NEEDLE GUIDE
CIVCO Medical Instruments Co., Inc.
IYO
Apr 15, 1988K875236TRANS/P NEEDLE GUIDE
CIVCO Medical Instruments Co., Inc.
IYO
Apr 15, 1988K875128TRANS/R NEEDLE GUIDE
CIVCO Medical Instruments Co., Inc.
IYO
Apr 14, 1988K880659TEKNAR PROSCAN ACCESSORY PROBE
Teknar, Inc.
IYO
Apr 14, 1988K875241CIVCO SEED IMPLANT NEEDLE GUIDE
CIVCO Medical Instruments Co., Inc.
IYO
Apr 7, 1988K873845SIM 4000I
Ote-Biomedica Elettronica S.P.A
IYO
Mar 31, 1988K880219TRANSRECTAL PROBE BD65S-TR
Elscint, Inc.
IYO
Mar 23, 1988K873937SDR 3500 (PHILIPS PLATINUM +)
Philips Ultrasound, Inc.
IYO
Mar 15, 1988K880081VISION CARE/PHAKOSYSTEMS ECHOPACH
Phakosystems, Inc., CA
IYO
Mar 15, 1988K880065NIDEK UP-2000
Nidek, Inc.
IYO
Mar 1, 1988K873159COMBISON(R) 310A REAL TIME ULTRASOUND SCANNER
Cone Instruments, Inc.
IYO
Jan 11, 1988K872288SONOLAYER-V, SAL-38B
Toshiba Medical Systems
IYO
Dec 11, 1987K871004EUB-410 DIAGNOSTIC ULTRASOUND DEVICE
Hitachi Medical Corp. of America
IYO
Dec 4, 1987K872726DGH-3000A A-SCAN
Dgh Technology, Inc.
IYO
Nov 23, 1987K873096COLOR FLOW IMAGING
Advanced Technology Laboratories, Inc.
IYO
Nov 23, 1987K871938VISION CARE/PHAKOSYSTEMS ECHORULE
Phakosystems, Inc., CA
IYO
Sep 8, 1987K872307VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB
General Electric Co.
IYO
Aug 26, 1987K871536OPHTHASONIC A-SCAN/ B-SCAN
Teknar, Inc.
IYO
Aug 19, 1987K854654SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007
Philips Medical Systems, Inc.
IYO
Aug 17, 1987K872027OLYMPUS GF-UM2/EU-M2
Olympus Corp.
IYO
Jul 10, 1987K864807TEKNAR PROSCAN(TM)
Teknar, Inc.
IYO
Mar 13, 1987K870964ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER
Elscint, Inc.
IYO
Feb 13, 1987K860581QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM
Quantum Medical Systems, Inc.
IYO
Jan 9, 1987K864336PACHYMETER SYSTEM V
CooperVision, Inc.
IYO
Jan 9, 1987K863947SONOLAYER-L, SAL-77B
Toshiba Medical Systems
IYO
Jan 5, 1987K862867EUB-310 ULTRASONIC SCANNER
Hitachi Medical Corp. of America
IYO
Dec 29, 1986K863780ADA-1000 (ADVANCED DIGITAL ARRAY)
Diasonics, Inc.
IYO
Dec 18, 1986K864398STORZ SOLID & ANGLED SOLID CONTACT PROBES
Storz Instrument Co.
IYO
Dec 18, 1986K860757OPHTHASONIC A-SCAN
Teknar, Inc.
IYO
Dec 12, 1986K863576EUB-400 DIAGNOSTIC ULTRASOUND DEVICE
Hitachi Medical Corp. of America
IYO
Dec 11, 1986K862127DYMAX PERSONAL SCANNER
Dymax Corp
IYO
Nov 28, 1986K862165ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340
Hitachi Medical Corp. of America
IYO
Nov 24, 1986K8633387.5 MHZ LINEAR SMALL PARTS PROBE
Siemens Medical Solutions USA, Inc.
IYO
Nov 10, 1986K8630965.O MHZ SECTOR PROBE, MODEL 8818106 LH 307
Siemens Medical Solutions USA, Inc.
IYO
Nov 10, 1986K8630433.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305
Siemens Medical Solutions USA, Inc.
IYO
Nov 10, 1986K8630413.5 MHZ SECTOR PROBE, MODEL 8818098 LH306
Siemens Medical Solutions USA, Inc.
IYO
Nov 4, 1986K862164EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER
Hitachi Medical Corp. of America
IYO
Oct 23, 1986K852502AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849
Bruel & Kjaer Industri A/S, DK
IYO
Sep 19, 1986K862151COLOR FLOW MAPPING (CFM) OPTION - MODEL 77020 CF
Hewlett-Packard Co.
IYO
Sep 4, 1986K854653CILCO SONOMETRICS DIGICON
CooperVision, Inc.
IYO
Aug 25, 1986K861538860 COLOR DOPPLER OR COLORVIEW 860
Ge Medical Systems Information Technologies
IYO
Aug 18, 1986K862166SONORANGER
Ausonics Pty , Ltd.
IYO
Jul 24, 1986K860697ULTRASOUND IMAGING SYSTEM MODEL 280 SL
Johnson & Johnson Professionals, Inc.
IYO
Jul 16, 1986K862681ULTRAMARK 1 ULTRASOUND SYSTEM
Advanced Technology Laboratories, Inc.
IYO
Jul 7, 1986K8601235.0 MHZ INTRAOPERATIVE ARRAY
Siemens Medical Solutions USA, Inc.
IYO
Jul 3, 1986K861376COMBISON R 320A
Cone Instruments, Inc.
IYO
Jun 30, 1986K861335STORZ COMPUSCAN 68K
Storz Instrument Co.
IYO
Jun 30, 1986K853565ARTIS ULTRASOUND IMAGING SYSTEM
Philips Medical Systems (Cleveland), Inc.
IYO

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