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)
Top companies in IYO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 16, 1986 | K860081 | ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS Elscint, Inc. | IYO |
| Jun 16, 1986 | K854959 | LINEAR SCANNER PROBE, MODEL TL-50 Elscint, Inc. | IYO |
| Apr 8, 1986 | K854389 | NIDEK US-1600 A-SCAN Nidek, Inc. | IYO |
| Mar 20, 1986 | K854668 | 5.0 MHZ LINEAR ARRAY SONOLINE PROBE Siemens Medical Solutions USA, Inc. | IYO |
| Mar 20, 1986 | K854667 | 7.5 MHZ LINEAR ARRAY SONOLINE PROBE Siemens Medical Solutions USA, Inc. | IYO |
| Mar 13, 1986 | K853147 | SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY Scano, Inc. | IYO |
| Mar 12, 1986 | K855124 | CONVEX PROBE, PVE-382M Toshiba Medical Systems | IYO |
| Mar 12, 1986 | K854555 | GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT Gl Ultrasound , Ltd., GB | IYO |
| Mar 10, 1986 | K860062 | OCULAB PACHPEN Oculab, Inc. | IYO |
| Mar 10, 1986 | K860061 | OCULAB BIOMETRICPEN Oculab, Inc. | IYO |
| Mar 10, 1986 | K852686 | SONOLINE CD Siemens Medical Solutions USA, Inc. | IYO |
| Feb 28, 1986 | K854743 | 2.5 MHZ PHASED ARRAY SECTOR MERIDIAN PROBE Johnson & Johnson Professionals, Inc. | IYO |
| Feb 27, 1986 | K854969 | CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) Cilco, Inc. | IYO |
| Feb 24, 1986 | K853739 | SONOLAYER SAL-55A/55AS Toshiba Medical Systems | IYO |
| Feb 13, 1986 | K853702 | ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN Johnson & Johnson Professionals, Inc. | IYO |
| Jan 30, 1986 | K852862 | CORNEO-GAGE TWO Sonogage, Inc. | IYO |
| Jan 16, 1986 | K853946 | SONOLINE LX Siemens Medical Solutions USA, Inc. | IYO |
| Jan 16, 1986 | K844112 | MYOPACH ULTRASONIC PACHOMETER Myocure, Inc. | IYO |
| Jan 13, 1986 | K853008 | SONOLINE SL-2(ULTRASOUND SCANNER) Siemens Medical Solutions USA, Inc. | IYO |
| Dec 31, 1985 | K851972 | DIASONICS ADA400 ADVANCED DIGITAL ARRAY Diasonics, Inc. | IYO |
| Dec 30, 1985 | K853217 | QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES Quantum Medical Systems, Inc. | IYO |
| Dec 23, 1985 | K854135 | HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A Hewlett-Packard Co. | IYO |
| Nov 13, 1985 | K853311 | LINEAR ARRAY PROBE PLB-310M FOR SAL-32B Toshiba Medical Systems | IYO |
| Oct 31, 1985 | K853116 | PAXIAL Biophysic Medical, Inc. | IYO |
| Oct 31, 1985 | K852362 | UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-52 Johnson & Johnson Professionals, Inc. | IYO |
| Oct 31, 1985 | K851860 | DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM Diasonics, Inc. | IYO |
| Oct 31, 1985 | K851446 | UNIVERSAL SERVICE MODULE Diasonics, Inc. | IYO |
| Oct 31, 1985 | K850834 | SDL-32 ELECTRONIC LINEAR SCANNER Shimadzu Corp. | IYO |
| Oct 16, 1985 | K853087 | STORZ SOLID-STANDOFF PACHYMETRY PROBE Storz Instrument Co. | IYO |
| Sep 27, 1985 | K851895 | POLYGEL ULTRASOUND GEL Parker Laboratories, Inc. | IYO |
| Sep 19, 1985 | K852571 | 3.5 MHZ LINEAR ARRAY, MODEL NO. 83, 39, 509 Siemens Medical Solutions USA, Inc. | IYO |
| Sep 19, 1985 | K852570 | 5.0 MHZ LINEAR ARRAY, MODEL 83, 39, 517 Siemens Medical Solutions USA, Inc. | IYO |
| Sep 19, 1985 | K851807 | RT2600(115V)(220/240V) #H4008A & H4008AE General Electric Co. | IYO |
| Sep 13, 1985 | K844686 | OPHTHASCAN B Biophysic Medical, Inc. | IYO |
| Sep 6, 1985 | K844184 | D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROB D.R.G. | IYO |
| Aug 14, 1985 | K852549 | SONORANGER Ausonics Pty , Ltd. | IYO |
| Aug 14, 1985 | K851982 | KITECKO ULTRASOUND STANDOFF PAD 3M Company | IYO |
| May 22, 1985 | K851696 | AUSONICS 150 Ausonics Pty , Ltd. | IYO |
| Apr 22, 1985 | K844916 | MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER Hoffrel Instruments, Inc. | IYO |
| Apr 18, 1985 | K850290 | ULTRASOUND GEL Litton Datamedix | IYO |
| Apr 18, 1985 | K844299 | CORNEOMAP 4500 Radionics Medical, Inc., CA | IYO |
| Apr 18, 1985 | K843994 | AUSONICS 357 Ausonics Pty , Ltd. | IYO |
| Apr 18, 1985 | K843971 | AUSONICS 150 Ausonics Pty , Ltd. | IYO |
| Apr 15, 1985 | K850478 | PLUS 1 Dymax Corp | IYO |
| Apr 10, 1985 | K844393 | GL ULTRASOUND SECTOR 170 Gl Ultrasound , Ltd., GB | IYO |
| Apr 3, 1985 | K850580 | DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 Elscint, Inc. | IYO |
| Mar 29, 1985 | K850116 | BETASONIC III Teknar, Inc. | IYO |
| Feb 26, 1985 | K843696 | OPHTHALMIC A-SCAN A-2000 SONOME Sonomed Technology, Inc. | IYO |
| Feb 25, 1985 | K843205 | GL ULTRASOUND Z/SL 8300 Gl Ultrasound , Ltd., GB | IYO |
| Feb 4, 1985 | K844404 | IREX PS, PORTABLE SCANNER AND 118 Irex Corp. | IYO |
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