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
Apr 10, 1980K800532S.K. DIAG. ULTRASOUND BODY SCANNER
Smithkline Diagnostics, Inc.
IYO
Apr 10, 1980K800531S.K. DIAG. ULTRASND. SMALL PARTS SCAN
Smithkline Diagnostics, Inc.
IYO
Apr 10, 1980K800434PORTABLE MEDICAL ULTRASOUND SCANNER
Bion Ent., Ltd.
IYO
Feb 21, 1980K8001007200 MA ECHO-OPHTHALMOSCOPE
Kt Medical, Inc.
IYO
Feb 21, 1980K800099INTRACULA II
Kt Medical, Inc.
IYO
Feb 19, 1980K791766ECHO-OCULOMETER #3000
Jedmed Instrument Co.
IYO
Feb 11, 1980K800139SEARLE PHO/SONIC ALPHA 2000
G.D. Searle and Co.
IYO
Feb 11, 1980K800094COMBISON 200 & COMBISON 202
Kt Medical, Inc.
IYO
Feb 11, 1980K800091COMBISON 100-MODEL 100 & 110
Kt Medical, Inc.
IYO
Feb 5, 1980K792492UCA GEL
Vanaray Laboratories, Inc.
IYO
Feb 5, 1980K792489UCA CREAM
Vanaray Laboratories, Inc.
IYO
Jan 28, 1980K792638HIGH RESOLUTION IMAGING SYSTEM
Unirad Corp.
IYO
Jan 21, 1980K792585SMV 120 SONIC MAMMOGRAPHIC VIEWER
Johnson & Johnson Professionals, Inc.
IYO
Jan 9, 1980K792446ADR REAL-TIME SECTOR SCANNER
Adr Ultrasound
IYO
Dec 20, 1979K792388OCTOSON
Ausonics Pty , Ltd.
IYO
Oct 26, 1979K791775VARIAN V-3300, PHASED ARRAY ULTRASON
Varian Assoc., Inc.
IYO
Oct 26, 1979K791755DATASON-GS
General Electric Co.
IYO
Oct 26, 1979K791744VARIAN V-3400, PHASED ARRAY ULTRASON
Varian Assoc., Inc.
IYO
Oct 4, 1979K791040SECTOR SCANNER, SDU-100, COMPUTERIZED
Shimadzu Corp.
IYO
Sep 27, 1979K791298DIAGNOSTIC ULTRASOUND SYSTEM
Xonics Medical Systems, Inc.
IYO
Sep 21, 1979K791429EMISONIC 4290
Emi Medical, Inc.
IYO
Sep 17, 1979K791505ROHNAR 7000 DIGITAL DIAGN ULTRASOUND
Roche Scientific Corp.
IYO
Sep 17, 1979K791344MODEL 1350 GRAPHICS TRANSLATOR
Hewlett-Packard Co.
IYO
Sep 17, 1979K791343MODEL 1338A CRT DISPLAY
Hewlett-Packard Co.
IYO
Aug 10, 1979K790694BRITT LENS COMPUTER
Britt Corp., Inc.
IYO
Aug 1, 1979K790321DATASON DB
General Electric Co.
IYO
Apr 23, 1979K790489MICROVIEW
Philips Medical Systems (Cleveland), Inc.
IYO
Mar 21, 1979K790396ULTRASONIC DIAGNOSTIC SYSTEM
Hoffrel Instruments, Inc.
IYO
Mar 8, 1979K790285IMAGER, PHO/SONIC SERIES 2000
G.D. Searle and Co.
IYO
Feb 12, 1979K790023OCCULAR COMPU-SCAN
Storz Instrument Co.
IYO
Jan 26, 1979K790037SONO TRAK T.M.
Narco Air-Shields
IYO
Jan 25, 1979K782158SCANNER-SV
Hrl, Inc.
IYO
Jan 3, 1979K781177ULTRASOUND BREAST SCANNING DEVICE
Life Instrument Corp.
IYO
Dec 20, 1978K782060MULTIFORMAT FILM CASSETTE TRANSPORT
Mediscan, Inc.
IYO
Oct 24, 1978K781709SCANNER, LINEAR
Philips Medical Systems (Cleveland), Inc.
IYO
Sep 26, 1978K781508WATERPATH SCANNING OPTION
G.D. Searle and Co.
IYO
Aug 21, 1978K781344OPTION PHO/SONIC B-MODE SCANNER
G.D. Searle and Co.
IYO
Jul 17, 1978K781079SONOGRAF ULTRASOUND B-SCANNING SYSTEM
Ohio Nuclear, Inc.
IYO
Jul 17, 1978K781051EMISONIC 4201
Emi Medical, Inc.
IYO
May 25, 1978K780578SONOGRAF EDP REAL-TIME ADAPTER
Foley, Lardner, Hollabaugh & Jacobs
IYO
Jan 12, 1978K770999LITTON 300L ULTRASOUND SYSTEM
Electra-Physics Laboratories, Inc.
IYO
Nov 7, 1977K772012VIDEO ADAPTER FOR GRAPHIC RECORDERS
Honeywell, Inc.
IYO
Oct 27, 1977K771930EMISONIC 4500 TM
Emi Medical, Inc.
IYO
Oct 25, 1977K771934LINEAR ARRAY B-MODE SCANNER
G.D. Searle and Co.
IYO
Sep 26, 1977K771688ECHO-OCULOMETER
Storz Instrument Co.
IYO
Sep 22, 1977K771600ULTRASOUND
Toshiba Medical Systems
IYO
Aug 16, 1977K771291IMAGE SCANNING TYPE SONOLAY. SAL-10A
Toshiba Medical Systems
IYO
Aug 3, 1977K771290CONTACT COMPOUNT SONOLAY. SAC-10A
Toshiba Medical Systems
IYO

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